FDA Fast Track Designation Program - SYNTA Pharmaceuticals
Let's not forget about the fast track designation..
September 12, 2013 08:00 AM
LEXINGTON, Mass.--(BUSINESS WIRE)--Synta Pharmaceuticals Corp. (NASDAQ: SNTA) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of ganetespib, the Company’s lead Hsp90 inhibitor drug candidate, to improve overall survival when administered in combination with docetaxel for the treatment of patients with metastatic non-small cell lung adenocarcinoma who have progressed following one prior chemotherapy regimen. FDA’s Fast Track Drug Development Program is designed to facilitate the clinical development and expedite the review of drugs that are intended to treat serious medical conditions and that demonstrate the potential to fill unmet medical needs.
“We are very pleased that FDA has granted this important designation to the ganetespib development program”
“We are very pleased that FDA has granted this important designation to the ganetespib development program,” said Safi Bahcall, President and CEO of Synta. “We look forward to continued progress and bringing ganetespib to cancer patients as quickly as possible.”
Ganetespib is currently being evaluated as a treatment of non-small cell lung adenocarcinoma in the GALAXY program, consisting of the GALAXY-1 Phase 2b/3 all-comer trial and the GALAXY-2 Phase 3 trial enriched for patients most likely to benefit from ganetespib treatment.
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Las Vegas, NV – March 26, 2014 — (Tech Sonian) – Synta Pharmaceuticals Corp. (SNTA) released that presentation of interim results from the ENCHANT-1 trial, a single-arm multi-center Phase 2 proof-of-concept study designed to calculate ganetespib, the Company’s lead drug applicant, administered as monotherapy for the treatment of metastatic breast cancer.