On Decmeber 23, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, today reports that it has initiated the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for afami-cel for use as a single-dose regimen for the treatment of advanced synovial sarcoma (Press release, Adaptimmune, DEC 23, 2022, View Source [SID1234625584]).

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"Adaptimmune’s goal is to design and deliver cell therapies to transform the lives of people with cancer," said Dennis Williams, PharmD, Senior VP of Late-Stage Development. "Initiation of this rolling BLA submission is an important milestone toward achieving this goal – bringing to market a new therapeutic option for people with advanced synovial sarcoma. This also marks an important milestone for the treatment of solid tumors with autologous T-cell products."

The BLA submission for afami-cel is supported by positive clinical data from Adaptimmune’s SPEARHEAD-1 clinical trial in patients with advanced synovial sarcoma. The Company plans to complete its rolling submission by mid-2023 and the application will be eligible for priority review under the FDA’s regenerative medicine advanced therapy (RMAT) program.