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FDA Rejects Breast Cancer Therapy Due to Safety Concerns
The FDA has issued a complete response letter (CRL) citing safety concerns responding to a New Drug Application (NDA) for oral paclitaxel plus encequidar to treat metastatic breast cancer.
According to a release from the manufacturer, the FDA was specifically concerned about the risk of an increase in neutropenia-related sequelae in the oral paclitaxel arm of a clinical trial compared to patients in the IV paclitaxel arm.
The letter also addressed uncertainties over the primary endpoint of objective response rate at week 19, noting that “the BICR reconciliation and re-read process may have introduced unmeasured bias and influence in the BICR.”
In its letter, the FDA recommended the manufacturer conduct a new trial studying patients with metastatic breast cancer “representative of the population in the US.”
The new trial, according to the letter, should have additional risk mitigation strategies for toxicity, including dose optimization and/or excluding patients at higher risk of toxicity.
“Our clinical and regulatory teams are disappointed by the complete response letter. We plan to work with the Agency to resolve the issues raised in the CRL and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancers,” Rudolf Kwan, MBBS, MRCP, Chief Medical officer of Athenex, said in the release.
The release noted that the manufacturer will request a meeting with the FDA to discuss the design and scope of the new trial to help with a potential future approval.
By Adam Hochron
According to a release from the manufacturer, the FDA was specifically concerned about the risk of an increase in neutropenia-related sequelae in the oral paclitaxel arm of a clinical trial compared to patients in the IV paclitaxel arm.
The letter also addressed uncertainties over the primary endpoint of objective response rate at week 19, noting that “the BICR reconciliation and re-read process may have introduced unmeasured bias and influence in the BICR.”
In its letter, the FDA recommended the manufacturer conduct a new trial studying patients with metastatic breast cancer “representative of the population in the US.”
The new trial, according to the letter, should have additional risk mitigation strategies for toxicity, including dose optimization and/or excluding patients at higher risk of toxicity.
“Our clinical and regulatory teams are disappointed by the complete response letter. We plan to work with the Agency to resolve the issues raised in the CRL and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancers,” Rudolf Kwan, MBBS, MRCP, Chief Medical officer of Athenex, said in the release.
The release noted that the manufacturer will request a meeting with the FDA to discuss the design and scope of the new trial to help with a potential future approval.
By Adam Hochron