Legend Biotech Announces Acceptance of Ciltacabtagene Autoleucel (Cilta-Cel) NDA in China

Legend Biotech Corp. announced that China’s National Medical Products Administration accepted its New Drug Application for ciltacabtagene autoleucel, a novel therapy to treat life-threatening diseases. This submission is based on findings from the confirmatory Phase 2 clinical study CARTIFAN-1 (NCT03758417) in China, which assessed the efficacy and safety of cilta-cel in adult patients with relapsed or refractory multiple myeloma who had previously received three or more lines of therapy, including a proteasome inhibitor and immunomodulatory drug.

Publish Date: 02-01-2023 Source: Legend Biotech Corp.

Multiple myeloma (MM) is a complex hematologic malignancy characterized by the uncontrolled proliferation of clonal plasma cells in the bone marrow that secrete large amounts of immunoglobulins and other non-functional proteins. Despite decades of progress and several landmark therapeutic advancements, MM remains incurable in most cases. These cells are hyperproliferative differentiated B-lymphocytes capable of secreting a variety of immunoglobulins (Ig), with the most common being IgG, IgA, and, to a lesser extent, IgD. The abnormal PCs typically grow in the bone marrow, with only a small fraction of patients presenting with extramedullary disease at the time of diagnosis. Most patients during treatment experience a relapse and progress to refractory and stop responding to treatment within 60 days of the last treatment, characterized by poor prognosis and a high risk of relapse. With each additional relapse, patients experience a shorter PFS. PFS in first-line patients were 18 months, but by the 4th line of therapy, PFS was only 4.7 months. The primary goal of treatment for relapsed MM is to alleviate disease symptoms and prevent the development of CRAB symptoms (Calcium > 11.5 mg/dL; creatinine > 2 mg/dL; haemoglobin < 10 g/dL or >2 points below the lower normal limit; new bone lesions). The treatment of RRMM is a complex and standard combination of proteasome inhibitors, immunomodulatory drugs and monoclonal antibodies, with the addition of histone deacetylase inhibitors and alkylating agents.

In the USA, the incidence of Multiple myeloma ranges from 5 to 9 cases per 100,000 population per year with 45% of 5-year survival.

However, the current Relapsed or Refractory Multiple Myeloma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (TKI258, AT9283, STI-6129, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Relapsed or Refractory Multiple Myeloma treatment. The key companies in the advanced development stage are Antengene Corporation, Zhejiang ACEA Pharmaceutical Co. Ltd., Astex Pharmaceuticals, Inc., etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Relapsed or Refractory Multiple Myeloma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

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