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FDA Fast Tracks Synta’s NSCLC Treatment

Ganetespib to help treat adenocarcinoma

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has granted Fast Track designation to the investigation of ganetespib, Synta Pharmaceuticals‘ 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,” 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 IIb/III all-comer trial and the GALAXY-2 Phase III trial enriched for patients most likely to benefit from ganetespib treatment.

Tom Wilson, Synta Pharmaceuticals’ vice president of Quality, will give the presentation, “Managing Virtual Manufacturing: The Perspective from a Small Company,” at Contracting & Outsourcing 2013 (Sept. 19-20). For more information, visit the conference site!

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