CARVYKTI (ciltacabtagene autoleucel) Receives Approval from Japan’s Ministry of Well being, Labour and Welfare (MHLW) for the Remedy of Sufferers with Relapsed

CARVYKTI (ciltacabtagene autoleucel) Receives Approval from Japan’s Ministry of Well being, Labour and Welfare (MHLW) for the Remedy of Sufferers with Relapsed

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SOMERSET, N.J.–(BUSINESS WIRE)–
Legend Biotech Company (NASDAQ: LEGN), a world biotechnology firm creating, manufacturing and commercializing novel therapies to deal with life-threatening ailments, introduced at present that Japan’s Ministry of Well being, Labour and Welfare (MHLW) has permitted CARVYKTI™ (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) remedy, for the remedy of adults with relapsed or refractory a number of myeloma, restricted to instances assembly each of the next situations:

  • Sufferers don’t have any historical past of CAR-positive T cell infusion remedy concentrating on BCMA
  • Sufferers who’ve acquired three or extra strains of therapies, together with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom a number of myeloma has not responded to or has relapsed following the newest remedy

The New Drug Software was submitted by Legend Biotech’s collaboration companion, Janssen Prescription drugs (Janssen). Legend entered into an unique worldwide license and collaboration settlement with Janssen to develop and commercialize ciltacabtagene autoleucel (cilta-cel) in December 2017.

CARVYKTI™ options two BCMA-targeting single area antibodies, is particularly developed for every particular person affected person and is run as a single infusion.

The approval is predicated on information from the pivotal section 1b/2 CARTITUDE-1 examine, and included sufferers who acquired a median of six prior remedy regimens (vary, 3-18), and beforehand acquired a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.1 Within the examine, a one-time remedy with ciltacabtagene autoleucel resulted in sturdy responses, with 96.9 % (95 % Confidence Interval [CI], 91.2-99.4) of sufferers with relapsed or refractory a number of myeloma (RRMM) within the non-Japanese inhabitants responding to remedy (n=97).1 Notably, 67 % (95 % CI, 56.7-76.2) of the sufferers (n=65) achieved a stringent full response (sCR), a measure for which a doctor is unable to look at any indicators or signs of illness through imaging or different checks after remedy.2* The efficacy outcomes had been additionally noticed in Japanese sufferers with a number of myeloma, which had been per that of the non-Japanese inhabitants.+ At a median of 18 months follow-up, the median length of response (DOR) was 21.8 months in non-Japanese sufferers.3

The protection of cilta-cel was evaluated in 106 grownup sufferers within the CARTITUDE-1 examine, together with 97 non-Japanese and 9 Japanese contributors. Antagonistic reactions had been noticed in 105 (99.1%) of 106 sufferers handled with cilta-cel. The most typical opposed reactions included cytokine launch syndrome (94.3%), cytopenia (79.2%), neutropenia (75.5%), thrombocytopenia (59.4%), anemia (51.9%), neurologic occasions (39.6%) infections (19.8%) and hypogammaglobulinemia (11.3%).4

Ying Huang, Ph.D., Chief Government Officer of Legend Biotech, mentioned: “The approval of CARVYKTI™ by the Japanese regulatory authority is a landmark on our journey to assist sufferers with relapsed or refractory a number of myeloma. In partnership with Janssen, we’re laying the groundwork for this drug to enter {the marketplace}, whereas advancing the medical improvement program for what we imagine to be a significant therapeutic choice for acceptable sufferers with a number of myeloma.”

CARVYKTI™ was permitted by the U.S. Meals and Drug Administration in February 2022 and was granted conditional advertising authorization by the European Fee in Might 2022.

– END –

About CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel)

CARVYKTI™ is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which includes reprogramming a affected person’s personal T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that categorical BCMA. BCMA is primarily expressed on the floor of malignant a number of myeloma B-lineage cells, in addition to late-stage B-cells and plasma cells. The CARVYKTI™ CAR protein options two BCMA-targeting single area antibodies designed to confer excessive avidity in opposition to human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, growth, and elimination of goal cells.1

In December 2017, Legend Biotech Company entered into an unique worldwide license and collaboration settlement with Janssen Prescription drugs (Janssen) to develop and commercialize cilta-cel.

In February 2022, CARVYKTI™ was permitted by the U.S. Meals and Drug Administration (FDA) for the remedy of adults with relapsed or refractory a number of myeloma.5 In Might 2022, the European Fee (EC) granted conditional advertising authorization of CARVYKTI™ for the remedy of adults with relapsed and refractory a number of myeloma.6 Cilta-cel was granted Breakthrough Remedy Designation within the U.S. in December 2019 and in China in August 2020. As well as, cilta-cel acquired a PRIority MEdicines (PRIME) designation from the European Fee in April 2019. Cilta-cel additionally acquired Orphan Drug Designation from the U.S. FDA in February 2019, from the European Fee in February 2020, and from the Prescription drugs and Medicinal Gadgets Company (PMDA) in Japan in June 2020. In Might 2022, the European Medicines Company’s Committee for Orphan Medicinal Merchandise really helpful by consensus that the orphan designation for cilta-cel be maintained on the idea of medical information demonstrating improved and sustained full response charges following remedy.7

About CARTITUDE-1

CARTITUDE-1 (NCT03548207)8 is a Part 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the remedy of grownup sufferers with relapsed or refractory a number of myeloma, who beforehand acquired a minimum of three prior strains of remedy together with a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody, and who demonstrated illness development on or after the final routine. All sufferers within the examine had acquired a median of six prior remedy regimens (vary, 3-18).9

About A number of Myeloma

A number of myeloma is an incurable blood most cancers that begins within the bone marrow and is characterised by an extreme proliferation of plasma cells.10 In Japan, roughly 7,800 folks had been identified with a number of myeloma in 2018 and about 4,200 sufferers died in 2020.11 In 2022, it’s estimated that greater than 34,000 folks shall be identified with a number of myeloma, and greater than 12,000 folks will die from the illness in the united states12 Whereas some sufferers with a number of myeloma don’t have any signs in any respect, most sufferers are identified as a consequence of signs that may embody bone issues, low blood counts, calcium elevation, kidney issues or infections.13 Though remedy might end in remission, sadly, sufferers will probably relapse.14 Sufferers who relapse after remedy with commonplace therapies, together with protease inhibitors, immunomodulatory brokers, and an anti-CD38 monoclonal antibody, have poor prognoses and few remedy choices out there.15,16

CARVYKTI™ U.S. FDA-Authorised Indication

CARVYKTI™ (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the remedy of grownup sufferers with relapsed or refractory a number of myeloma, after 4 or extra prior strains of remedy, together with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

U.S. IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, and PROLONGED and RECURRENT CYTOPENIA

Cytokine Launch Syndrome (CRS), together with deadly or life-threatening reactions, occurred in sufferers following remedy with CARVYKTI™. Don’t administer CARVYKTI™ to sufferers with lively an infection or inflammatory issues. Deal with extreme or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

Immune Effector Cell-Related Neurotoxicity Syndrome (ICANS), which can be deadly or life-threatening, occurred following remedy with CARVYKTI™, together with earlier than CRS onset, concurrently with CRS, after CRS decision, or within the absence of CRS. Monitor for neurologic occasions after remedy with CARVYKTI™. Present supportive care and/or corticosteroids as wanted.

Parkinsonism and Guillain-Barré syndrome and their related issues leading to deadly or life-threatening reactions have occurred following remedy with CARVYKTI™.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), together with deadly and life-threatening reactions, occurred in sufferers following remedy with CARVYKTI™. HLH/MAS can happen with CRS or neurologic toxicities.

Extended and/or recurrent cytopenias with bleeding and an infection and requirement for stem cell transplantation for hematopoietic restoration occurred following remedy with CARVYKTI™.

CARVYKTI™ is accessible solely by way of a restricted program beneath a Danger Analysis and Mitigation Technique (REMS) known as the CARVYKTI™ REMS Program.

WARNINGS AND PRECAUTIONS

Cytokine Launch Syndrome (CRS) together with deadly or life-threatening reactions, occurred following remedy with CARVYKTI™ in 95% (92/97) of sufferers receiving ciltacabtagene autoleucel. Grade 3 or larger CRS (2019 ASTCT grade)1 occurred in 5% (5/97) of sufferers, with Grade 5 CRS reported in 1 affected person. The median time to onset of CRS was 7 days (vary: 1-12 days). The most typical manifestations of CRS included pyrexia (100%), hypotension (43%), elevated aspartate aminotransferase (AST) (22%), chills (15%), elevated alanine aminotransferase (14%) and sinus tachycardia (11%). Grade 3 or larger occasions related to CRS included elevated AST and ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, respiratory failure, acute kidney damage, disseminated intravascular coagulation, HLH/MAS, angina pectoris, supraventricular and ventricular tachycardia, malaise, myalgias, elevated C-reactive protein, ferritin, blood alkaline phosphatase and gamma-glutamyl transferase.

Establish CRS primarily based on medical presentation. Consider for and deal with different causes of fever, hypoxia, and hypotension. CRS has been reported to be related to findings of HLH/MAS, and the physiology of the syndromes might overlap. HLH/MAS is a probably life-threatening situation. In sufferers with progressive signs of CRS or refractory CRS regardless of remedy, consider for proof of HLH/MAS.

Sixty-nine of 97 (71%) sufferers acquired tocilizumab and/or a corticosteroid for CRS after infusion of ciltacabtagene autoleucel. Forty-four (45%) sufferers acquired solely tocilizumab, of whom 33 (34%) acquired a single dose and 11 (11%) acquired multiple dose; 24 sufferers (25%) acquired tocilizumab and a corticosteroid, and one affected person (1%) acquired solely corticosteroids. Be certain that a minimal of two doses of tocilizumab can be found previous to infusion of CARVYKTI™.

Monitor sufferers a minimum of day by day for 10 days following CARVYKTI™ infusion at a REMS-certified healthcare facility for indicators and signs of CRS. Monitor sufferers for indicators or signs of CRS for a minimum of 4 weeks after infusion. On the first signal of CRS, instantly institute remedy with supportive care, tocilizumab, or tocilizumab and corticosteroids. Counsel sufferers to hunt quick medical consideration ought to indicators or signs of CRS happen at any time. Neurologic toxicities, which can be extreme, life-threatening or deadly, occurred following remedy with CARVYKTI™.

Neurologic toxicities, which can be extreme, life-threatening or deadly, occurred following remedy with CARVYKTI™. Neurologic toxicities included ICANS, neurologic toxicity with indicators and signs of parkinsonism, Guillain-Barré Syndrome, peripheral neuropathies, and cranial nerve palsies. Counsel sufferers on the indicators and signs of those neurologic toxicities, and on the delayed nature of onset of a few of these toxicities. Instruct sufferers to hunt quick medical consideration for additional evaluation and administration if indicators or signs of any of those neurologic toxicities happen at any time.

Total, a number of subtypes of neurologic toxicity described under occurred following ciltacabtagene autoleucel in 26% (25/97) of sufferers, of which 11% (11/97) of sufferers skilled Grade 3 or larger occasions. These subtypes of neurologic toxicities had been additionally noticed in two ongoing research.

Immune Effector Cell-Related Neurotoxicity Syndrome (ICANS): Sufferers receiving CARVYKTI™ might expertise deadly of life-threatening ICANS following remedy with CARVYKTI™, together with earlier than CRS onset, concurrently with CRS, after CRS decision, or within the absence of CRS.

ICANS occurred in 23% (22/97) of sufferers receiving ciltacabtagene autoleucel together with Grade 3 or 4 occasions in 3% (3/97) and Grade 5 (deadly) occasions in 2% (2/97). The median time to onset of ICANS was 8 days (vary 1-28 days). All 22 sufferers with ICANS had CRS. Essentially the most frequent (≥5%) manifestation of ICANS included encephalopathy (23%), aphasia (8%) and headache (6%). Monitor sufferers a minimum of day by day for 10 days following CARVYKTI™ infusion on the REMS-certified healthcare facility for indicators and signs of ICANS. Rule out different causes of ICANS signs.

Monitor sufferers for indicators or signs of ICANS for a minimum of 4 weeks after infusion and deal with promptly. Neurologic toxicity needs to be managed with supportive care and/or corticosteroids as wanted.

Parkinsonism: Of the 25 sufferers within the CARTITUDE-1 examine experiencing any neurotoxicity, 5 male sufferers had neurologic toxicity with a number of indicators and signs of parkinsonism, distinct from immune effector cell-associated neurotoxicity syndrome (ICANS). Neurologic toxicity with parkinsonism has been reported in different ongoing trials of ciltacabtagene autoleucel. Sufferers had parkinsonian and nonparkinsonian signs that included tremor, bradykinesia, involuntary actions, stereotypy, lack of spontaneous actions, masked facies, apathy, flat have an effect on, fatigue, rigidity, psychomotor retardation, micrographia, dysgraphia, apraxia, lethargy, confusion, somnolence, lack of consciousness, delayed reflexes, hyperreflexia, reminiscence loss, issue swallowing, bowel incontinence, falls, stooped posture, shuffling gait, muscle weak spot and losing, motor dysfunction, motor and sensory loss, akinetic mutism, and frontal lobe launch indicators. The median onset of parkinsonism within the 5 sufferers in CARTITUDE-1 was 43 days (vary 15-108) from infusion of ciltacabtagene autoleucel.

Monitor sufferers for indicators and signs of parkinsonism which may be delayed in onset and managed with supportive care measures. There’s restricted efficacy info with medicines used for the remedy of Parkinson’s illness, for the development or decision of parkinsonism signs following CARVYKTI™ remedy.

Guillain-Barré Syndrome: A deadly final result following Guillain-Barré Syndrome (GBS) has occurred in one other ongoing examine of ciltacabtagene autoleucel regardless of remedy with intravenous immunoglobulins. Signs reported embody these per MillerFisher variant of GBS, encephalopathy, motor weak spot, speech disturbances and polyradiculoneuritis.

Monitor for GBS. Consider sufferers presenting with peripheral neuropathy for GBS. Think about remedy of GBS with supportive care measures and at the side of immunoglobulins and plasma change, relying on severity of GBS.

Peripheral Neuropathy: Six sufferers in CARTITUDE-1 developed peripheral neuropathy. These neuropathies offered as sensory, motor or sensorimotor neuropathies. Median time of onset of signs was 62 days (vary 4-136 days), median length of peripheral neuropathies was 256 days (vary 2-465 days) together with these with ongoing neuropathy. Sufferers who skilled peripheral neuropathy additionally skilled cranial nerve palsies or GBS in different ongoing trials of ciltacabtagene autoleucel.

Cranial Nerve Palsies: Three sufferers (3.1%) skilled cranial nerve palsies in CARTITUDE-1. All three sufferers had seventh cranial nerve palsy; one affected person had fifth cranial nerve palsy as effectively. Median time to onset was 26 days (vary 21-101 days) following infusion of ciltacabtagene autoleucel. Incidence of third and sixth cranial nerve palsy, bilateral seventh cranial nerve palsy, worsening of cranial nerve palsy after enchancment, and prevalence of peripheral neuropathy in sufferers with cranial nerve palsy have additionally been reported in ongoing trials of ciltacabtagene autoleucel. Monitor sufferers for indicators and signs of cranial nerve palsies. Think about administration with systemic corticosteroids, relying on the severity and development of indicators and signs.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Deadly HLH occurred in a single affected person (1%), 99 days after ciltacabtagene autoleucel. The HLH occasion was preceded by extended CRS lasting 97 days. The manifestations of HLH/MAS embody hypotension, hypoxia with diffuse alveolar harm, coagulopathy, cytopenia, and multi-organ dysfunction, together with renal dysfunction. HLH is a life-threatening situation with a excessive mortality fee if not acknowledged and handled early. Remedy of HLH/MAS needs to be administered per institutional requirements.

CARVYKTI™ REMS: Due to the chance of CRS and neurologic toxicities, CARVYKTI™ is accessible solely by way of a restricted program beneath a Danger Analysis and Mitigation Technique (REMS) known as the CARVYKTI™ REMS.

Additional info is accessible at www.CARVYKTIrems.com or 1-844-672-0067.

Extended and Recurrent Cytopenias: Sufferers might exhibit extended and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI™ infusion. One affected person underwent autologous stem cell remedy for hematopoietic reconstitution as a consequence of extended thrombocytopenia.

In CARTITUDE-1, 30% (29/97) of sufferers skilled extended Grade 3 or 4 neutropenia and 41% (40/97) of sufferers skilled extended Grade 3 or 4 thrombocytopenia that had not resolved by Day 30 following ciltacabtagene autoleucel infusion.

Recurrent Grade 3 or 4 neutropenia, thrombocytopenia, lymphopenia and anemia had been seen in 63% (61/97), 18% (17/97), 60% (58/97), and 37% (36/97) after restoration from preliminary Grade 3 or 4 cytopenia following infusion. After Day 60 following ciltacabtagene autoleucel infusion, 31%, 12% and 6% of sufferers had a recurrence of Grade 3 or larger lymphopenia, neutropenia and thrombocytopenia, respectively, after preliminary restoration of their Grade 3 or 4 cytopenia. Eighty-seven % (84/97) of sufferers had one, two, or three or extra recurrences of Grade 3 or 4 cytopenias after preliminary restoration of Grade 3 or 4 cytopenia. Six and 11 sufferers had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, on the time of demise.

Monitor blood counts previous to and after CARVYKTI™ infusion. Handle cytopenias with development elements and blood product transfusion help in keeping with native institutional pointers.

Infections: CARVYKTI™ shouldn’t be administered to sufferers with lively an infection or inflammatory issues. Extreme, life-threatening or deadly infections occurred in sufferers after CARVYKTI™ infusion.

Infections (all grades) occurred in 57 (59%) sufferers. Grade 3 or 4 infections occurred in 23% (22/97) of sufferers; Grade 3 or 4 infections with an unspecified pathogen occurred in 17%, viral infections in 7%, bacterial infections in 1%, and fungal infections in 1% of sufferers. Total, 4 sufferers had Grade 5 infections: lung abscess (n=1), sepsis (n=2) and pneumonia (n=1).

Monitor sufferers for indicators and signs of an infection earlier than and after CARVYKTI™ infusion and deal with sufferers appropriately. Administer prophylactic, pre-emptive and/or therapeutic antimicrobials in keeping with the usual institutional pointers. Febrile neutropenia was noticed in 10% of sufferers after ciltacabtagene autoleucel infusion and could also be concurrent with CRS. Within the occasion of febrile neutropenia, consider for an infection and handle with broad-spectrum antibiotics, fluids and different supportive care, as medically indicated.

Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some instances leading to fulminant hepatitis, hepatic failure and demise, can happen in sufferers with hypogammaglobulinemia. Carry out screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV), or some other infectious brokers if clinically indicated in accordance with medical pointers earlier than assortment of cells for manufacturing. Think about antiviral remedy to forestall viral reactivation per native institutional pointers/medical apply.

Hypogammaglobulinemia was reported as an opposed occasion in 12% (12/97) of sufferers; laboratory IgG ranges fell under 500 mg/dL after infusion in 92% (89/97) of sufferers. Monitor immunoglobulin ranges after remedy with CARVYKTI™ and administer IVIG for IgG

Use of Dwell Vaccines: The protection of immunization with stay viral vaccines throughout or following CARVYKTI™ remedy has not been studied. Vaccination with stay virus vaccines will not be really helpful for a minimum of 6 weeks previous to the beginning of lymphodepleting chemotherapy, throughout CARVYKTI™ remedy, and till immune restoration following remedy with CARVYKTI™.

Hypersensitivity Reactions have occurred in 5% (5/97) of sufferers following ciltacabtagene autoleucel infusion. Critical hypersensitivity reactions, together with anaphylaxis, could also be because of the dimethyl sulfoxide (DMSO) in CARVYKTI™. Sufferers needs to be rigorously monitored for two hours after infusion for indicators and signs of extreme response. Deal with promptly and handle appropriately in keeping with the severity of the hypersensitivity response.

Secondary Malignancies: Sufferers might develop secondary malignancies. Monitor life-long for secondary malignancies. Within the occasion {that a} secondary malignancy happens, contact Janssen Biotech, Inc., at 1-800-526-7736 for reporting and to acquire directions on assortment of affected person samples for testing of secondary malignancy of T cell origin.

Results on Potential to Drive and Use Machines: Because of the potential for neurologic occasions, together with altered psychological standing, seizures, neurocognitive decline, or neuropathy, sufferers are in danger for altered or decreased consciousness or coordination within the 8 weeks following CARVYKTI™ infusion. Advise sufferers to chorus from driving and fascinating in hazardous occupations or actions, equivalent to working heavy or probably harmful equipment throughout this preliminary interval, and within the occasion of recent onset of any neurologic toxicities.

ADVERSE REACTIONS

The most typical non-laboratory opposed reactions (incidence better than 20%) are pyrexia, cytokine launch syndrome, hypogammaglobulinemia, hypotension, musculoskeletal ache, fatigue, infections of unspecified pathogen, cough, chills, diarrhea, nausea, encephalopathy, decreased urge for food, higher respiratory tract an infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting. The most typical laboratory opposed reactions (incidence better than or equal to 50%) embody thrombocytopenia, neutropenia, anemia, aminotransferase elevation, and hypoalbuminemia.

Please learn full Prescribing Info together with Boxed Warning for CARVYKTI™.

About Legend Biotech

Legend Biotech is a world biotechnology firm devoted to treating, and at some point curing, life-threatening ailments. Headquartered in Somerset, New Jersey, we’re creating superior cell therapies throughout a various array of know-how platforms, together with autologous and allogeneic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and pure killer (NK) cell-based immunotherapy. From our three R&D websites all over the world, we apply these progressive applied sciences to pursue the invention of protected, efficacious and cutting-edge therapeutics for sufferers worldwide.

Study extra at www.legendbiotech.com and observe us on Twitter and LinkedIn.

Cautionary Be aware Relating to Ahead-Trying Statements

Statements on this press launch about future expectations, plans and prospects, in addition to some other statements concerning issues that aren’t historic details, represent “forward-looking statements” inside the which means of The Personal Securities Litigation Reform Act of 1995. These statements embody, however should not restricted to, statements referring to Legend Biotech’s methods and goals; statements referring to CARVYKTI™, together with Legend Biotech’s expectations for CARVYKTI™, equivalent to Legend Biotech’s manufacturing and commercialization expectations for CARVYKTI™ and the potential impact of remedy with CARVYKTI™; statements about submissions for cilta-cel to, and the progress of such submissions with, the U.S. Meals and Drug Administration (FDA), the European Medicines Company (EMA), the Chinese language Middle for Drug Analysis of Nationwide Medical Merchandise Administration (CDE) and different regulatory authorities; the anticipated timing of, and skill to progress, medical trials; the power to take care of and progress the conditional advertising authorization for cilta-cel granted by the EMA; the submission of Investigational New Drug (IND) functions to, and upkeep of such functions with, regulatory authorities; the power to generate, analyze and current information from medical trials; and the potential advantages of Legend Biotech’s product candidates. The phrases “anticipate,” “imagine,” “proceed,” “might,” “estimate,” “count on,” “intend,” “might,” “plan,” “potential,” “predict,” “venture,” “ought to,” “goal,” “will,” “would” and comparable expressions are meant to establish forward-looking statements, though not all forward-looking statements include these figuring out phrases. Precise outcomes might differ materially from these indicated by such forward-looking statements because of numerous vital elements. Legend Biotech’s expectations might be affected by, amongst different issues, uncertainties concerned within the improvement of recent pharmaceutical merchandise; surprising medical trial outcomes, together with because of extra evaluation of current medical information or surprising new medical information; surprising regulatory actions or delays, together with requests for extra security and/or efficacy information or evaluation of knowledge, or authorities regulation usually; surprising delays because of actions undertaken, or failures to behave, by our third social gathering companions; uncertainties arising from challenges to Legend Biotech’s patent or different proprietary mental property safety, together with the uncertainties concerned within the U.S. litigation course of; competitors normally; authorities, business, and basic public pricing and different political pressures; the length and severity of the COVID-19 pandemic and governmental and regulatory measures carried out in response to the evolving state of affairs; in addition to the opposite elements mentioned within the “Danger Components” part of the Legend Biotech’s Annual Report on Type 20-F filed with the Securities and Trade Fee on March 31, 2022. Ought to a number of of those dangers or uncertainties materialize, or ought to underlying assumptions show incorrect, precise outcomes might fluctuate materially from these described on this press launch as anticipated, believed, estimated or anticipated. Any forward-looking statements contained on this press launch converse solely as of the date of this press launch. Legend Biotech particularly disclaims any obligation to replace any forward-looking assertion, whether or not because of new info, future occasions or in any other case.

* The info cut-off is September 1, 2020, a minimum of 6 months after the administration of final affected person.

+ The info cut-off is July 22, 2021, a minimum of 12 months after the administration of final affected person.

1 CARVYKTI Package deal Insert, Japan.

2 Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell remedy in sufferers with relapsed or refractory a number of myeloma (CARTITUDE-1): a section 1b/2 open-label examine. Lancet, 2021; 398: 314-24.

3 Usmani, S. Ciltacabtagene autoleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T-cell (CAR-T) remedy, in relapsed/refractory a number of myeloma (R/R MM): Up to date outcomes from CARTITUDE-1. Summary #8005 [Oral]. Offered at 2021 American Society of Medical Oncology (ASCO) Annual Assembly.

4 World section Ib/II examine in sufferers with relapsed or refractory a number of myeloma (MMY2001 examine) (permitted on September 26, 2022, CTD2.7.6.1) (This displays the analysis information on the time of approval)

5 CARVYKTI™ (ciltacabtagene autoleucel), BCMA-Directed CAR-T Remedy, Receives U.S. FDA Approval for the Remedy of Grownup Sufferers with Relapsed or Refractory A number of Myeloma. Out there at: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-bcma-directed-car-t-therapy-receives-u-s-fda-approval-for-the-treatment-of-adult-patients-with-relapsed-or-refractory-multiple-myeloma/. Final accessed: September 2022.

6 CARVYKTI (ciltacabtagene autoleucel) Granted Conditional Approval by the European Fee for the Remedy of Sufferers with Relapsed and Refractory A number of Myeloma. Out there at: https://legendbiotech.com/legend-news/carvykti-ciltacabtagene-autoleucel-granted-conditional-approval-by-the-european-commission-for-the-treatment-of-patients-with-relapsed-and-refractory-multiple-myeloma/. Final accessed: September 2022.

7 European Fee. Group Register of Orphan Medicinal Merchandise. Out there at: https://ec.europa.eu/well being/paperwork/community-register/html/o2252.htm. Final accessed: Might 2022.

8 CARTITUDE-2 (NCT04133636). Out there at: https://clinicaltrials.gov/ct2/present/NCT04133636. Accessed Might 2022.

9 ClinicalTrials.gov. A Examine of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Remedy Directed Towards B-Cell Maturation Antigen (BCMA) in Contributors With Relapsed or Refractory A number of Myeloma (CARTITUDE-1). Out there at: https://clinicaltrials.gov/ct2/present/NCT03548207 Final accessed September 2022.

10 American Society of Medical Oncology. A number of myeloma: introduction. Out there at: https://www.most cancers.web/cancer-types/multiple-myeloma/introduction.

11 Nationwide Most cancers Middle Most cancers Info Service: A number of Myeloma. Out there at: https://ganjoho.jp/reg_stat/statistics/stat/most cancers/26_mm.html#anchor1

12 American Most cancers Society. “Key Statistics About A number of Myeloma.” Out there at: https://www.most cancers.org/most cancers/multiple-myeloma/about/key-statistics.html.

13 American Most cancers Society. A number of myeloma: early detection, analysis and staging. Out there at: https://www.most cancers.org/content material/dam/CRC/PDF/Public/8740.00.pdf. Accessed February 2022

14 Rajkumar SV. A number of myeloma: 2020 replace on analysis, risk-stratification and administration. Am J Hematol. 2020;95(5),548-567. doi:10.1002/ajh.25791.

15 Kumar SK, Dimopoulos MA, Kastritis E, et al. Pure historical past of relapsed myeloma, refractory to immunomodulatory medicine and proteasome inhibitors: a multicenter IMWG examine. Leukemia. 2017;31(11):2443-2448.

16 Gandhi UH, Cornell RF, Lakshman A, et al. Outcomes of sufferers with a number of myeloma refractory to CD38-targeted monoclonal antibody remedy. Leukemia. 2019;33(9):2266-2275.

CARVYKTI (ciltacabtagene autoleucel) Receives Approval from Japan’s Ministry of Well being, Labour and Welfare (MHLW) for the Remedy of Sufferers with Relapsed

Investor Contacts:

Joanne Choi, Senior Supervisor, Investor Relations, Legend Biotech

[email protected]

Crystal Chen, Supervisor, Investor Relations, Legend Biotech

[email protected]

Press Contact:

Tina Carter, Company Communications Lead, Legend Biotech

[email protected]

(908) 331-5025

Supply: Legend Biotech Company

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