Adaptimmune Receives FDA Accelerated Approval for T Cell Receptor Cell Therapy in Rare Soft Tissue Cancer

Approval Details::

The FDA granted accelerated approval to Adaptimmune's TECELRA (afamitresgene autoleucel) for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and meet specific HLA and MAGE-A4 antigen criteria.

First of Its Kind::

TECELRA is the first engineered cell therapy approved for a solid tumor cancer in the U.S. and the first new treatment option for synovial sarcoma in over a decade.

Clinical Efficacy::

The approval was based on the SPEARHEAD-1 trial, which showed an overall response rate (ORR) of 43% and a median duration of response of 6 months.

Treatment and Administration::

TECELRA is administered as a single intravenous dose and is designed to target the MAGE-A4 antigen expressed by cancer cells in synovial sarcoma.

Market and Availability::

The therapy will be available at authorized treatment centers, with Adaptimmune planning to have six to ten centers operational this year and thirty within two years.

Pricing::

TECELRA is priced at $727,000 per dose, reflecting its clinical value for a rare and high-need patient population.

Future Plans::

Adaptimmune plans to submit confirmatory trial results next year to maintain the approval and is advancing other investigational treatments, including lete-cel for sarcoma.

Company Background::

Adaptimmune, founded in 2008, has faced significant challenges but achieved a milestone with this approval, marking a significant step forward in cell therapy for solid tumors.