FDA Approves Gedatolisib in Breast Cancer - Takeaways - MDSpire

FDA Approves Gedatolisib in Breast Cancer

In VIKTORIA-1, gedatolisib-containing regimens resulted in longer median progression-free survival than fulvestrant alone.

  • By

  • Kathryn Wighton

  • July 14, 2026

  • 2 min

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    The FDA approved gedatolisib for adults with hormone receptor-positive, HER2-negative breast cancer after endocrine therapy progression.

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    Efficacy was evaluated in the VIKTORIA-1 trial, which enrolled 392 patients with advanced or metastatic breast cancer.

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    Median progression-free survival was 9.3 months for gedatolisib, fulvestrant, and palbociclib compared to 2.0 months for fulvestrant alone.

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    Objective response rates were 32% with the three-drug regimen and 28% with gedatolisib and fulvestrant, versus 1% with fulvestrant alone.

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    Warnings include stomatitis, dermatologic reactions, hyperglycemia, and embryo-fetal toxicity; the recommended dosage is 180 mg weekly.

Original Source(s)

FDA Approves Gedatolisib in Breast Cancer

  • by Kathryn Wighton

  • July 14, 2026

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