[이코노믹리뷰=황진중 기자] The approval of the US Food and Drug Administration (FDA) for the new oral anticancer drug’Oraxol’, which Hanmi Pharm (128940) transferred technology to the US pharmaceutical bio company Atenex, was frustrated. The FDA recommended that a new clinical trial be conducted, such as requesting Athenex to supplement the data.
Athenex announced on the 1st (local time) that it has received a supplementary request letter (CRL) in response to the application for product approval (NDA) for the treatment of metastatic breast cancer from Roxol.
According to the explanation, the FDA has completed a review of Axol’s NDA, but has withheld approval for safety concerns. Regarding safety concerns, it is pointed out that as a result of the Phase 3 clinical trial submitted by Artenex, the neutrophilia-related sequelae was higher in the oxisol group compared to the paclitaxel intravenous formulation (IV) group.
There were also concerns about the objective response rate (ORR), which is the primary efficacy evaluation index for Phase III clinical trials. FDA noted that there may be unmeasured biases and impacts on the primary end result of the 19-week target ORR conducted by the Independent Review Committee (BICR).
The FDA recommends that Atenex conduct a new, adequate and well-performed clinical trial in a population of metastatic breast cancer patients representing the United States. FDA recommended that additional risk mitigation strategies be established to improve toxic reactions. Risk mitigation strategies include dose optimization and excluding patients deemed to have a higher risk of toxicity.
Athenex will request a meeting with the FDA to discuss its response later and discuss its clinical design and scope. It will then coordinate the next steps necessary to address FDA’s requirements and obtain approval.
“We were disappointed with the response letter,” said Rudolph Kwan, Chief Medical Officer at Atenex. “We plan to work with the agency to resolve the issues raised at the CRL and obtain approval for Rexol in metastatic breast cancer. I emphasized.
On the other hand, Axol is a new anticancer drug that Hanmi Pharm transferred its technology to Artenex in December 2011. Rexol has applied’Oras Covery’, a bio-platform technology that can convert an injectable anticancer drug into an oral formulation.