The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025

Three specific FDA decisions from late 2024 reveal important trends that could influence development strategies throughout 2025. While year-end approval counts focus on quantity, these approvals signal evolving regulatory preferences that forward-thinking sponsors should understand.

The first dual HER2-targeted antibody approved for biliary tract cancer represents FDA's growing confidence in biomarker-driven approvals for rare tumor types. The decision suggests willingness to extrapolate from larger indications when biomarker rationale is compelling and unmet need is high.

A new CAR T-cell therapy option for relapsed/refractory ALL demonstrates continued regulatory support for cellular therapies, but with increasingly sophisticated manufacturing and safety requirements. The approval pathway offers insights into what FDA expects from next-generation CAR-T programs.

Perhaps most instructively, a withdrawn application's successful refinement toward accelerated approval shows how sponsors can recover from initial setbacks. The refined submission addressed specific FDA concerns about endpoint selection and patient population definition—issues that other sponsors facing similar feedback should note carefully.

Former FDA Oncology Division Director, Harpreet Singh, M.D., breaks down what these approvals signal about pathway selection, submission timing, and the regulatory strategies most likely to succeed in the current environment.