Puma Biotechnology lung cancer candidate IND cleared by FDA

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• The US FDA has cleared an Investigational New Drug application from Puma Biotechnology (NASDAQ:PBYI) for its small cell lung cancer candidate alisertib.
• Puma (PBYI) will begin a phase 2 trial this half of the year with up to 60 lung cancer patients who progressed after platinum-based chemotherapy and immunotherapy.
• The primary objective will be objective response rate.
• Puma also intends on examining alisertib, an oral drug that inhibits aurora kinase A, in breast cancer.
• Despite the development, shares are down 5% in Tuesday premarket trading.

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