प्राथमिक स्रोत रिकॉर्ड
निर्णायकFDA मंज़ूरी
Celcuity: FDA ने HR+/HER2- PIK3CA-wt स्तन कैंसर में REVTORPYK (gedatolisib) को मंज़ूरी दी
The FDA granted full approval for REVTORPYK (gedatolisib) in combination with fulvestrant ± palbociclib for HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer after endocrine therapy. This is the first pan-PI3K/mTORC1/2 inhibitor approved, supported by Phase 3 VIKTORIA-1 data showing 76% and 67% risk reductions in progression or death for the triplet and doublet regimens, respectively.
मुख्य तथ्य
- फाइल किया गया
- 14 जुल॰ 2026, 09:39 pm
- घटना
- FDA मंज़ूरी
- दिशा
- सकारात्मक
- कंपनी
CELCCelcuity- संपत्ति
- gedatolisib
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- HR
- 0.50
- OR
- 49%
- माध्य DOR
- 15.7 महीने
- माध्य PFS
- 11.1 बनाम 5.6 महीने
स्रोत का अंश
EX-99.1 2 ex99-1.htm EX-99.1 Exhibit 99.1 Celcuity Announces FDA Approval of REVTORPYK™ (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer - REVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 - In the Phase 3 VIKTORIA-1 trial, REVTORPYK combined with palbociclib and fulvestrant and REVTORPYK combined with fulvestrant reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant among patients with PIK3CA wild-type advanced or metastatic breast cancer - Celcuity to host webcast and conference call today Tuesday, July 14, 2026, at 5:30 p.m. EDT MINNEAPOLIS, July 14, 2026 — Celcuity Inc. (Nasdaq: CEL
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