JW Therapeutics Announces NMPA Acceptance of the Supplemental New Drug Application for Carteyva® in Patients with Relapsed or Refractory Follicular Lymphoma
JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China accepted the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL). This is the second marketing application on Carteyva® submitted by JW Therapeutics, and is expected to be the first cell therapy product approved in China for the treatment of r/r FL patients. Carteyva® was granted Breakthrough Therapy Designation by NMPA in September 2020.
The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva® in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China. The study results were presented at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021. The cohort B results showed that Carteyva® demonstrated very high rates of durable disease response (Best Complete Response Rate and Overall Response Rate at 3 months was 92.6% and 100%, respectively) and controllable CAR-T associated toxicities in patients with r/r FL (42.9% and 17.9% of the patients had any grade Cytokine Release Syndrome (CRS) and Neurotoxicity (NT), while 0% and 3.6% of the patients experienced CRS and NT of Grade 3 or above).
Professor Yuqin Song, Chief Physician of Lymphoma Department at Peking University Cancer Hospital, Director of China Society of Clinical Oncology (CSCO), noted at the 63rd American Society of Hematology (ASH) Annual Meeting: “The RELIANCE study results show that Carteyva® demonstrated very excellent efficacy and safety profile in patients with r/r FL and we are looking forward to the sNDA approval in China.”
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