[Monday Newspaper = Reporter Cho Heung-seop]The oral anti-cancer drug’Oraxol’, which Hanmi Pharm has exported to the US pharmaceutical company Artenex, was not approved by the US Food and Drug Administration (FDA).
Artenex announced on the 1st (local time) that it has received a supplementary request letter (CRL) from the FDA for marketing approval of’Orasol’, a metastatic breast cancer treatment.
Rexol is a new drug that converts the intravenous anticancer drug’paclitaxel’ into an edible form. In 2011, Hanmi Pharmaceutical exported the technology to Atenex in the US.
The FDA is known to have raised concerns about the neutropenic sequelae compared to intravenous injections of Axol, an oral anticancer drug.
They also expressed concern about the uncertainty of the results of the objective response rate (ORR), the primary endpoint evaluated by the Independent Central Review Committee (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.
“(FDA) has informed us of the need for additional strategies to improve safety, such as optimizing dosage for approval of a potential marketing license,” said Artenex.
Athenex will discuss FDA’s requirements for clinical trial design and scope, and will 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 recreational sol.”