March 2, 2024

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Milestone: First TCR-T Therapy Files for Approval

Milestone: First TCR-T Therapy Files for Approval

Milestone: First TCR-T Therapy Files for Approval

On January 31, 2024, Adaptimmune announced that the market application for their TCR-T therapy, Afami-cel, has been accepted by the FDA and granted priority review status, with a PDUFA date set for August 4 of this year.

Milestone: First TCR-T Therapy Files for Approval

Afami-cel marks Adaptimmune’s inaugural pipeline, targeting MAGE-A4, designed for the treatment of a type of soft tissue tumor known as synovial sarcoma.

This therapy holds the potential to be the first T-cell therapy for solid tumors, making it a groundbreaking achievement if successfully approved.

Synovial sarcoma, a subtype of soft tissue tumors, accounts for approximately 5-10% of the 13,000 new cases of soft tissue tumors diagnosed annually in the United States. The five-year survival rate for synovial sarcoma is merely 20%, highlighting a significant unmet clinical need.

Adaptimmune anticipates a peak sales value of $400 million for the combined Afami-cel and lete-cel therapies.

Afami-cel has demonstrated a 39% Objective Response Rate (ORR) in later-line treatments.

With a two-year survival rate of 70%, Afami-cel’s median Overall Survival (mOS) is estimated at 17 months, surpassing historical data with a comparison of less than 12 months.


In summary, the success of Afami-cel is a milestone, indicating a shift in cancer treatment targets from membrane/extracellular to intracellular domains, opening up new possibilities in target selection.

The approval of Afami-cel is eagerly awaited, offering improved treatment options for synovial sarcoma patients. 

Milestone: First TCR-T Therapy Files for Approval

(source:internet, reference only)

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Important Note: The information provided is for informational purposes only and should not be considered as medical advice.