Input 2021-03-02 14:54 | Revision 2021-03-02 14:54
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The approval of the US Food and Drug Administration (FDA) for Hanmi Pharmaceutical’s new oral anticancer drug’Oraxol’ has been delayed.
Hanmi Pharmaceutical’s partner Atenex announced on the 1st local time that it received a supplementary request letter (CRL) from the FDA for the marketing approval of’Orasol’, a metastatic breast cancer treatment.
Rexol is a new drug that Hanmi Pharmaceuticals technology exported to Athenex in the United States in 2011, and applied the platform technology’Oras Covery’ to convert the intravenous anticancer drug paclitaxel into oral use.
Earlier, in September last year, the FDA designated Axol as the subject of priority review, and the review period was shortened to within six months.
According to Atenex, the FDA raised concerns about the sequelae of neutropenia compared to intravenous injection of roxol, an oral anticancer drug.
FDA also expressed concern over the uncertainty of the results of the objective response rate (ORR), the primary endpoint evaluated by the Independent Central Review Board (BICR) at Week 19.
He also advised the need to conduct appropriate new clinical trials in patients with metastatic breast cancer in the United States to evaluate additional safety data.
Athenex plans to discuss the FDA’s requirements for clinical trial design and scope, and as the next step, it will request a meeting with the FDA to coordinate marketing approval approval.
An official at Hanmi Pharmaceutical said, “I am very sorry for the FDA’s decision,” and said, “I will seek the best way to obtain approval for marketing of Oraxol.”
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