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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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