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Oncologic Drugs Advisory Committee

On Wednesday, May 24, 2017, in the morning session of the Oncologic Drugs Advisory Committee (ODAC) meeting, the Committee supported by a vote of 12-Yes to 4-No, with no abstentions, the risk-benefit profile of neratinib maleate by Puma Biotechnology (Puma) for the extended adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified in adult breast cancer patients who have received prior therapy with trastuzumab (US trade name Herceptin).

In the afternoon session, the Committee supported, by a vote of 10-Yes to 3-No, with no abstentions, the risk-benefit profile of L-glutamine by Emmaus Medical, Inc. (Emmaus) for the treatment of Sickle Cell Disease.