SOMERSET, NJ – (BUSINESS WIRE) – Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of new cell therapies for oncology and other indications, announced that the Food and Drug Administration (FDA (CAR-T). The Prescription Drug User Fee Act (PDUFA) target action date has been set for November 29, 2021.

Priority review is usually given to investigational therapies which, if approved, can offer significant improvements in the treatment, prevention or diagnosis of serious disease. 1 Cilta-cel previously received Revolutionary therapy designation in December 2019, which aims to accelerate the development and review of a potential new drug. 2

“Cilta-cel has shown great promise in treating patients with heavily pretreated multiple myeloma according to study results reported to date. Today’s priority review designation marks another milestone for this cell therapy, ”said Ying Huang, PhD, CEO and CFO of Legend Biotech. “We look forward to continuing our collaborative efforts with Janssen and working with the FDA to bring this transformative therapy to patients who need new treatment options.”

The regulatory submission for cilta-cel is based on the results of the pivotal Phase 1b / 2 CARTITUDE-1 study which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed multiple myeloma and / or refractory. Updated longer-term follow-up data will be presented at the next American Society of Clinical Oncology (ASCO) annual meeting (Abstract # 8005) and the virtual congress of the European Hematology Association (EHA) (Abstract # EP964) next month.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a phase 1b / 2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and / or refractory multiple myeloma who have received at least 3 prior lines of treatment or which are double refractory to multiple myeloma. proteasome inhibitor (PI) and immunomodulatory drug (IMiD), received PI, IMiD and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent treatment.3 The primary objective of the phase 1b portion of the study was to characterize the safety and confirm the recommended phase 2 dose of cilta-cel, informed by the first human study with CAR-T LCAR cells -B38M (LEGEND-2). The phase 2 part further evaluated the efficacy of cilta-cel with the overall response rate as the primary endpoint.

About multiple myeloma

Multiple myeloma is an incurable cancer of the blood that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment can lead to remission, unfortunately, patients are very likely to relapse.5 Recurrent myeloma occurs when the disease has come back after a period of initial, partial, or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma occurs when a patient’s disease either does not respond or progresses within 60 days of their last treatment.7.8 While some patients with multiple myeloma have no symptoms, most patients are diagnosed due to symptoms that may include bone problems, low blood count, elevated calcium, kidney problems, or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have a poor prognosis and few treatment options available.ten

About Cilta-cel

Cilta-cel is an investigational chimeric antigen receptor (CAR-T) T cell therapy that is being investigated in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in the first lines of treatment . The design consists of a structurally differentiated CAR-T with two single domain antibodies targeting BCMA. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a breakthrough therapy designation granted in the United States in December 2019, cilta-cel received a Priority Drug Designation (PRiME) from the European Commission in April 2019 and a BTD in China in August 2020. Designations from Orphan drugs were also granted for cilta-cel by the US FDA in February 2019 and by the European Commission in February 2020. A biologics license application requesting approval of cilta-cel has been accepted by the US FDA and a Marketing authorization request has been accepted by the European Medicines Agency.

About Legend Biotech

Legend Biotech is a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our team of more than 900 employees in the United States, China and Europe, along with our differentiated technology, global development, and manufacturing strategies and expertise, give us great potential to discover, develop and manufacture the best-in-class cell therapies. for patients in need.

We are engaged in a strategic collaboration to develop and commercialize our lead product candidate, cilta-cel, a BCMA-targeted CAR-T cell therapy for patients with multiple myeloma. This candidate is currently being investigated in clinical trials for registration.

To learn more about Legend Biotech, visit us on LinkedIn, or on Twitter @LegendBiotech or on www.legendbiotech.com.

Caution Regarding Forward-Looking Statements

The statements contained in this press release about future expectations, plans and prospects, as well as any other statements concerning matters which are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. from 1995. These statements include, but are not limited to, statements regarding the timing and results of regulatory reviews relating to cilta-cel, including the US FDA accepted BLA and EMA accepted MAA, and the potential of cilta-cel as a safe and effective treatment. The words “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “can”, “plan”, “potential”, “foresee” , “Plan”, “should”, “target”, “will”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by these forward-looking statements due to various important factors, including the factors discussed in the “Risk Factors” section of the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 2, 2021. All forward-looking statements contained in this press release speak only as of the date hereof, and Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. . Readers should not trust any information on this page to be current or accurate after the date of publication.

The references

  1. US Food and Drug Administration. “Priority review” Available at http://www.fda.gov/forpatients/approvals/fast/ucm405405.htm. Accessed May 2021.

  2. US Food and Drug Administration. “Frequently Asked Questions: Revolutionary Therapies” Available at https://www.fda.gov/regulatory-information/food-and-drug-administration-safety-and-innovation-act-fdasia/freually-asked-questions-breakthrough-therapies#:~:text=Fast%20Track % 20Designation% 3A% 20Fast% 20track, fill% 20an% 20unmet% 20medical% 20need. Accessed May 2021.

  3. ClinicalTrials.gov. A study of JNJ-68284528, a chimeric antigen receptor (CAR-T) T cell therapy directed against B cell maturation antigen (BCMA) in participants with relapsed or refractory multiple myeloma (CARTITUDE-1 ). Available at: https://clinicaltrials.gov/ct2/show/NCT03548207. Last consulted in May 2021.

  4. American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Accessed November 2020.

  5. Abdi J, Chen G, Chang H et al. Drug resistance in multiple myeloma: latest findings and new concepts on molecular mechanisms. Oncotarget. 2013; 4: 2186-2207.

  6. National Cancer Institute. NCI Dictionary of Cancer Terms: Relapse. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=45866. Accessed November 2020.

  7. National Cancer Institute. NCI Dictionary of Cancer Terms: Refractory. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms?CdrID=350245. Accessed November 2020.

  8. Richardson P., Mitsiades C, Schlossman R, et al. Treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007: 317-23.

  9. American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed November 2020.

  10. Kumar SK, Lee JH, Lahuerta JJ et al. Risk of progression and survival in relapsed multiple myeloma after treatment with IMiD and bortezomib: a multicenter study by an international myeloma working group. Leukemia. 2012; 26: 149-57.



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