Hanmi Pharm's Tech-Out 'Oracsol' Fails to Obtain FDA Approval... "Request for Data Supplementation"

[Asia Economy Reporter Seo So-jung] Hanmi Pharmaceutical's anticancer drug 'Oraloxal,' which was licensed out to the US company Athenex in 2011, has not received approval from the US Food and Drug Administration (FDA).

On the 1st (local time), Athenex announced that it received a Complete Response Letter (CRL) from the FDA regarding the marketing approval of Oraloxal, an oral anticancer drug for the treatment of metastatic breast cancer.

According to Athenex, the FDA raised concerns about the risk of neutropenia as a side effect compared to intravenous administration of Oraloxal, an oral anticancer drug. Neutropenia is a condition in which the number of neutrophils in white blood cells abnormally decreases due to anticancer treatment, among other causes.

The FDA expressed concerns about the uncertainty of the objective response rate (ORR), the primary endpoint evaluated by the Blinded Independent Central Review (BICR) at week 19, and advised that an appropriate new clinical trial targeting metastatic breast cancer patients in the US is necessary to evaluate additional safety data.

They also indicated that additional strategies to improve safety, such as optimizing the dosing regimen, are needed for potential marketing approval.

In response, Athenex plans to discuss the clinical trial design and scope required by the FDA and request a meeting with the FDA to coordinate the next steps toward marketing approval.

Athenex stated, "We deeply regret the FDA's decision and will seek the best path to obtain marketing approval for Oraloxal."

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