Fast Track Designation for Custirsen for mCRPC

OncoGenex announced that the FDA has granted Fast Track designation to custirsen when given in combination with cabazitaxel/prednisone for the treatment of metastatic castration-resistant prostate cancer (CRPC) after prior treatment with a docetaxel-containing regimen.

Custirsen (OGX-011) is designed to block the production of the protein clusterin, which then alters tumor dynamics, slows tumor growth and resistance to partner treatments, so that the benefits of therapy, including survival, may be extended.

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OncoGenex is planning on enrolling approximately 630 men into its international, randomized, open-label Phase 3 AFFINITY trial. The study is designed to evaluate the survival outcomes of prostate cancer patients treated with custirsen and second-line chemotherapy cabazitaxel/prednisone compared to second-line chemotherapy alone.

The FDA has previously granted custirsen Fast Track status for the treatment of metastatic non-small cell lung cancer (NSCLC) and for mCRPC.

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