SYNTA'S MELANOMA DRUG GRANTED FAST-TRACK DESIGNATION

Synta Pharmaceuticals announced that its lead oncology drug candidate, STA-4783, has been granted fast-track designation by the FDA for the treatment of metastatic melanoma. In a recently completed Phase IIb, double-blind, randomized, controlled clinical trial in patients with Stage IV metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival.

The FDA's fast-track program is designed to facilitate the development and expedite the review of new drug candidates that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs. Fast-track designation allows a company to file a new drug application (NDA) on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. The designation also may facilitate more frequent interactions with the FDA and may lead to a priority review, which could decrease the typical review period. However, the designation has no impact on the standard of review or on whether the FDA ultimately approves the drug for marketing.

A total of 81 patients were enrolled in the Phase IIb trial, which compared the effects of treatment with STA-4783 plus paclitaxel to treatment with paclitaxel alone. The primary endpoint of this trial was progression-free survival, which is the time from randomization until death or objective tumor progression, as defined by the industry standard Response Evaluation Criteria in Solid Tumors. In the intent-to-treat analysis, which includes all 81 patients, treatment improved the median progression-free survival from 1.84 months for patients receiving paclitaxel alone to 3.68 months for those receiving paclitaxel plus STA-4783. STA-4783 was generally well tolerated in this study, and the incidences of adverse events (including Grade 3 and above) were generally comparable between the two groups.