CAR T-Cell skördar nya segrar

Adaptimmune announced that the FDA accepted the Biologics License Application for Afami-cel, its T-cell therapy to treat Advanced Synovial Sarcoma. A regulatory decision date is set for August 4, 2024. 

Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review

 January 31, 2024 4:44pm EST

Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January 31, 2024) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024.

About Afami-cel
Afami-cel is an engineered T-cell receptor (TCR) T-cell therapy, targeted to the MAGE A4 cancer target, and designed as a single-dose treatment for advanced synovial sarcoma. The last FDA approved therapy for treatment in this setting was for Votrient in 2012. The BLA submission for afami-cel was supported by clinical data from the SPEARHEAD-1 pivotal trial, which has met its primary endpoint for efficacy. ~39% of patients who received afami-cel had clinical responses with a median duration of response of ~12 months (CTOS 2022). Median overall survival (mOS) was ~17 months in SPEARHEAD-1 compared to historical mOS of <12 months for people with synovial sarcoma who received two or more prior lines of therapy.1 Seventy percent of people with advanced synovial sarcoma who respond to afami-cel are alive two years post-treatment.

Bristol Myers Squibb announced that supplemental regulatory applications for its CAR-T cell therapy were accepted in the US to treat R/R Follicular Lymphoma (FL) and R/R Mantle Cell Lymphoma. (MCL) A supplemental application to treat FL was accepted in Japan.

Regulatory Applications Accepted in the U.S. and Japan for Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL)

01/30/2024

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced three regulatory acceptances from the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi^® (lisocabtagene maraleucel). In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzito expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi). The FDA has granted both applications Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 23, 2024 for Breyanzi in relapsed or refractory FL and May 31, 2024 for Breyanzi in relapsed or refractory MCL.

Japan's MHLW has also accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.

“Patients living with follicular lymphoma and mantle cell lymphoma often experience cycles of remission and relapse with multiple lines of treatment, and we are committed to delivering innovative treatment solutions to this population,” said Anne Kerber, M.D., senior vice president, Head of Late Clinical Development, Hematology, Oncology, Cell Therapy (HOCT), Bristol Myers Squibb. “Breyanzi offers the potential for durable response, and these filing acceptances in the U.S. and Japan support our commitment to delivering our best-in-class CAR T cell therapy treatments to as many eligible patients as possible.”

Clinical Trials Supporting Regulatory Applications for Breyanzi in FL and MCL

In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study, which represents the largest clinical trial to date evaluating a CAR T cell therapy in patients with relapsed or refractory indolent B cell non-Hodgkin lymphoma (NHL), including high-risk second-line FL. In the study, Breyanzi demonstrated high rates of complete responses.

In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study, in which Breyanzi demonstrated statistically significant and clinically meaningful responses in heavily pre-treated patients, with the majority of patients achieving a complete response.

In both studies, Breyanzi demonstrated a consistent safety profile with no new safety signals reported. Results from both trials were presented at the 2023 International Conference on Malignant Lymphoma (ICML) in June 2023 and at the American Society of Hematology (ASH) Annual Meeting in December 2023.

A sBLA for Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received a prior BTKi and B-cell lymphoma 2 inhibitor is also currently under Priority Review with the FDA with an assigned target action date of March 14, 2024.

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