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Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

 
• By Bridget Silverman

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

T cell and pipette
Cancer is poised to remain the dominate approval category in 2024. • Source: Shutterstock

A string of complete response letters from the US FDA clouded the 2024 outlook for novel cancer therapies, but a productive pipeline is carrying enough candidates towards second half user fee goal dates to keep oncology the biggest area of approvals yet again for the full year.

Key Takeaways

  • One-third of novel agents with user fee goals in the rest of the year are intended for cancer patients, keeping oncology in position to remain dominate in 2024 despite five first-half complete response letters.

  • Five cell and gene therapies constitute CBER’s second half user fee calendar, which precludes another record-breaking year like 2023 – but still on track for a historically high number of novel biologic approvals

While about 20% of first half approvals were in the oncology space, one-third of the upcoming 2024 user fee goal dates are for products targeting cancer patients – primarily treatments, but also imaging and supportive care, the Pink Sheet US FDA Performance Tracker’s

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