New Gene & Cell Therapy Approval Announced

 
The US Food and Drug Administration (FDA) has granted accelerated approval to Adaptimmune LLC for its therapy, Tecelra® afamitresgene autoleucel (afami-cel), formerly ADP-A2M4, for the treatment of Synovial Sarcoma.

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We are here for you and look forward to answering your questions or sharing news on this approval as more information becomes available.

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Drug Category
Cell Therapy
Drug Name
Tecelra ® afamitresgene autoleucel (afami-cel)
FDA Approval Date
8/1/2024
Anticipated Cost
$727,000
Medical Condition
Synovial Sarcoma
FDA Approval Indication
For the treatment of 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.

Tecelra is contraindicated in adults who are heterozygous or homozygous for HLA-A*02:05P
US Incidence &
US Prevalence
Synovial sarcoma is the fourth most commonly occurring sarcoma, accounting for eight-10 percent of all sarcomas.
Prevalence is estimated to be 2.75 per 100,000 and is found to be slightly higher in males than females. The incidence is estimated to be 900 new cases a year in the United States.

One-third of those affected are under age 30 people with Li-Fraumeni syndrome and neurofibromatosis are associated with having a higher risk of developing synovial sarcoma.
Key Considerations
  • Inpatient
  • FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma | FDA
ICD-10 Codes
C49.0 -C49.9
J Codes
Generic code: C399 and J3590
For full label information and more, visit TECELRA® (afamitresgene autoleucel)

Our PULSE + Plus® Clinical Consultants are here to help you navigate the process and answer your questions about all things gene and cell therapy related. Our commitment is to provide you offerings that deliver the best clinical and financial outcome, while delivering ongoing support every step of the way.


 

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