[서울=뉴스핌] Reporter Jeong Seung-won = Hanmi Pharm’s oral anticancer drug, Oxol, for metastatic breast cancer treatment, received a request for supplemental marketing approval in the US
Hanmi Pharmaceutical’s US partner Atenex announced on the 1st (local time) that it received a complete response letter (CRL) from the FDA for the marketing approval of the oral anticancer drug Axol for metastatic breast cancer treatment.
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| Hanmi Pharmaceutical Headquarters [사진= 한미약품] |
According to Atenex, the FDA raised concerns about the sequelae of neutropenia compared to intravenous injections of Oxol, an oral anticancer drug.
In addition, FDA expressed concern over the uncertainty of the outcome of the objective response rate (ORR), the primary endpoint evaluated by the blinded independent central review (BICR) at Week 19. He advised that appropriate new clinical trials in patients need to be performed.
In addition, he pointed out that additional strategies to improve safety, such as optimizing the dosage, are needed for approval of potential marketing authorization.
As a result, Artenex plans to discuss the FDA’s requirements for clinical trial design and scope, and ask the FDA for a meeting to coordinate marketing approval approval as the next step.
Artenex said, “We are very sorry for the FDA’s decision,” and said, “We will seek the best way to obtain marketing approval of Entertainment.”