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  6. FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma
  1. Resources for Information | Approved Drugs

FDA D.I.S.C.O. Burst Edition: FDA approval of Tecelra (afamitresgene autoleucel) for unresectable or metastatic synovial sarcoma

Podcast

Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer therapeutic approval.

On August 2, 2024, the FDA granted accelerated approval to afamitresgene autoleucel (brand name TECELRA), a melanoma-associated antigen A4 (or MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

Efficacy was evaluated in SPEARHEAD-1, Cohort 1, a multicenter, single-arm, open-label clinical trial that enrolled HLA-A*02:01-03 and 06 allele positive patients with inoperable or metastatic synovial sarcoma who had received prior systemic therapy with either doxorubicin and/or ifosfamide and whose tumor expressed the MAGE-A4 tumor antigen. Patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide.

The main efficacy outcome measure was overall response rate according to RECIST v1.1 evaluated by independent review, supported by duration of response. Overall response rate was 43.2%. The median time to response was 4.9 weeks. The median duration of response was 6 months. Among patients who were responsive to the treatment, 45.6% and 39.0% had a duration of response greater than or equal to 6 months and 12 months, respectively.

The prescribing information includes a Boxed Warning for serious or fatal cytokine release syndrome, which may be severe or life-threatening.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Full prescribing information for this approval can be found on the web at www.fda.gov, with key word search “Approved Cellular and Gene Therapy Products”.

Health care professionals should report serious adverse events to www.fda.gov/medwatch.

Follow the Division of Drug Information on X @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov. Thanks for tuning in to the D.I.S.C.O. Burst Edition.

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