Q2 2024
Newsletters and Drug Reports

Newly Approved Tecelra (FKA Afami-Cell) - Afamitresgene Autoleucel

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Tecelra (FKA Afami-Cel) - Afamitresgene autoleucel manufactured by Adaptimmune received accelerated

approval from  the FDA on August 6, 2024. The wholesale acquisition price for the cell therapy only is 727K. The risk threshold for the therapy (the highest you should expect to pay) is $1.4 million.

 

 The anticipated cost of therapy plus administration, with no complications, is 950K-1 million. It is the first engineered cell therapy to receive approval for a solid tumor and the first T cell receptor (TCR) therapy to enter the U.S. market. Tecelra is a genetically

modified T cell immunotherapy made from patient’s own white blood cells, which are engineered to

recognize and attack cancer cells. Tecelra is FDA approved for the treatment of adults with unresectable

or metastatic synovial sarcoma who have had 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 detected

by an FDA-approved test.

 

Pre-treatment prophylactic medications and a 7 day admission are required as well as post- infusion

monitoring for at least 7 days. If complications occur, particularly severe cytokine release syndrome,

recovery may require extended hospitalization. Costs of total care needs can exceed $1,500,000.

 

Soft tissue sarcomas (STS) are a rare group of tumors that can found in any part of the body.

80% of all sarcomas are soft tissue in origin, 20% are associated with bone. Synovial sarcoma represents

5% of all the soft tissue sarcomas. Approximately 13,600 new cases will be diagnosed in 2024 with

an estimated mortality rate of 5,200. STS only account for 1% of all adult malignancies and ~15%

of childhood cancers. The 5-year survival rate for synovial sarcoma is 75%.