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FDA Approves Drugs for MCL, Colorectal and Breast Cancers

January 18, 2025

Three cancer drugs separately earned FDA approval:

The KRAS inhibitor sotorasib (Lumakras; Amgen) was approved for use with the EGFR inhibitor panitumumab (Vectibix; Amgen) to treat patients with metastatic colorectal cancer with a KRASG12C mutation. Regulators based their decision on results of the phase III CodeBreaK 300 trial in which progression-free survival (PFS) was 5.6 months for those who received the combination versus 2 months for those who received investigator’s choice standard trifluridine/tipiracil or regorafenib (Stivarga; Bayer).

The Bruton tyrosine kinase inhibitor acalabrutinib (Calquence; AstraZeneca) was approved for use with bendamustine and the anti-CD20 mAb rituximab (BR) to treat adults newly diagnosed with mantle cell lymphoma (MCL). In the phase III ECHO trial, that combination led to a 32% improvement in PFS over a placebo plus BR, but it elicited serious adverse reactions in 69% of patients.

Regulators also greenlighted datopotamab deruxtecan (Datroway; Daiichi Sankyo) for adults with inoperable, metastatic HR-positive, HER2-negative breast cancer who’ve already received an endrocrine-based therapy and chemotherapy. The TROP2-directed antibody–drug conjugate improved PFS by 2 months over investigator’s choice of chemotherapy but yielded no significant improvement in overall survival.

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