The FDA has issued a complete response letter (CRL) for Athenex Inc’s (NASDAQ: ATNX) marketing application seeking approval for oral paclitaxel plus encequidar to treat metastatic breast cancer.
The CRL indicated concern about an increase in neutropenia-related sequelae observed on the oral paclitaxel arm compared with the IV paclitaxel arm.
The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate at week 19 conducted by blinded independent central review (BICR).
It suggested that the BICR was influenced.
The agency recommended that the company conduct a new trial and adopt additional risk mitigation strategies to improve toxicity.
Athenex plans to request a meeting with the FDA to discuss the agency’s response.
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