ATNX - Athenex down big on FDA rejection of oral paclitaxel application in breast cancer

Athenex (ATNX) slumps 22% premarket after receiving a complete response letter ((CRL)) from the FDA regarding its New Drug Application ((NDA)) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.The FDA indicated that the review cycle is complete and that the application is not ready for approval in its present form. The Agency indicated its concern of safety risk in terms of an increase in neutropenia-related sequelae on the oral paclitaxel arm compared with the IV paclitaxel arm. Uncertainty over the results of the primary endpoint of objective response rate at week 19 was also worrisome. The Agency stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR. Athenex was recommended to conduct a new adequate and well-conducted clinical trial in a patients with breast cancer.The Agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization/exclusion of

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Athenex down big on FDA rejection of oral paclitaxel application in breast cancer