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Celcuity获得批准的乳腺癌治疗gedatolisib

2026-07-15 04:58

The US FDA has approved Celcuity's (CELC) Revtorpyk (gedatolisib) in combination with fulvestrant, with or without palbociclib, for HR+/HER- breast cancer following one line of endocrine therapy.
Approval was based on results from the VIKTORIA-1 trial that showed significant improvement in progression-free survival with gedatolisib. Treatment also led to improvement in overall survival, objective response rate, and duration of response.
Gedatolisib is dosed via intravenous infusion weekly on days 1, 8, and 15 of every 28-day cycle.

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