The FDA Approval of Afamitresgene Autoleucel for Synovial Sarcoma

The FDA Approval of Afamitresgene Autoleucel for Synovial Sarcoma

The FDA recently granted accelerated approval to afamitresgene autoleucel (afami-cel, Tecelra) for the treatment of advanced synovial sarcoma. This marks a significant milestone as it is the first engineered cell therapy indicated for a solid tumor.

Afami-cel is an autologous T-cell immunotherapy that is specifically indicated for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy. Patients eligible for this treatment must be HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and have a tumor that expresses the MAGE-A4 antigen, as determined by a companion diagnostic.

The approval of afami-cel was based on results from cohort 1 of the SPEARHEAD-1 trial, which included 44 patients with advanced synovial sarcoma. The one-time treatment with afami-cel resulted in an overall response rate of 43.2% and a complete response rate of 4.5%. The median duration of response was 6 months, with 39% of responders having a response lasting a year or longer.

Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, highlighted the importance of this approval, stating that synovial sarcoma continues to have a devastating impact on individuals, especially those for whom standard treatments have limited efficacy. With this approval, afami-cel becomes the first new therapeutic option in over a decade for synovial sarcoma.

Similar to CAR T-cell therapies, afami-cel carries a boxed warning for cytokine release syndrome (CRS). In trials, CRS occurred in 75% of patients (2% grade ≥3) with common symptoms including fever, tachycardia, hypotension, nausea/vomiting, and headache. The side effect was managed with tocilizumab (Actemra) in 55% of patients who experienced CRS. Other common adverse events with afami-cel included nausea, vomiting, fatigue, infections, pyrexia, and more.

The FDA approval of afamitresgene autoleucel represents a significant advancement in the treatment of synovial sarcoma. This engineered cell therapy provides an important new option for patients with this rare form of cancer and marks a milestone in the use of cell therapies for solid tumor cancers. However, it is important to carefully consider the potential adverse effects and risks associated with this treatment before proceeding with afami-cel.

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