The U.S. FDA has issued a complete response letter (CRL) for Athenex's marketing application seeking approval for oral paclitaxel plus encequidar to treat metastatic breast cancer.
Known as Oraxol, Athenex’s lead cancer program was expected to achieve blockbuster sales. In September 2020, the FDA granted a priority review designation to the new drug application based on the phase 3 findings.
In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm. Additionally, the agency expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR). The FDA said that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.
Johnson Lau, CEO of the small Buffalo, NY-based biopharma said the company is "surprised and disappointed by the FDA’s decision" during a recent earnings call.
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, engage in a dialogue on the design and scope of a clinical trial to address the FDA’s requirements and align on the next steps required to obtain approval.
Read the press release