A Drug Technology Licensed out to Athenex of the U.S.
Hanmi Pharmaceutical has failed to receive approval for its anti-cancer substance "Oraxol" from the U.S. Food and Drug Administration (FDA).
Hanmi Pharmaceutical licensed out Oraxol technology to Athenex, a U.S. pharmaceutical company, in 2011. Athenex said on March 1 (local time) that it has received a complete response letter (CRL) from the FDA for the company’s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer.
The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.
Oraxol is one of Hanmi’s two new drug candidate substances expected to be approved by the FDA in 2021. Hanmi Pharmaceutical applied its "Orascovery” platform technology to this candidate material. Orascovery technology converts anticancer injections to anticancer tablets.
In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.
The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR). The Agency stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.
The FDA recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S.
In addition, it advised Athenex to draw up additional risk mitigation strategies to improve toxicity, which may involve dose optimization and / or exclusion of patients deemed to be at higher risk of toxicity, to win approval of the NDA.
Athenex plans to discuss the design and scope of a clinical trial to address the FDA’s requirements and align on the next steps required to obtain approval.