Hanmi Pharmaceuticals, a renowned South Korean pharmaceutical firm, has reportedly announced that its new oral anticancer drug, Oraxol, has been assigned the priority review designation by the United States Food and Drug Administration (US FDA).
Speaking on the same, Athenex, partner of Hanmi stated that with the FDA accepting the application review for marketing authorization to treat NDA (metastatic breast cancer), priority review was designated to Axol.
The ‘Priority Review’ system of the FDA decides whether to approve new drugs or not in less than 6 months. It is reserved for drugs that can substantially enhance the safety and efficacy in the diagnosis, treatment, and prevention of critical diseases. The normal screening process generally takes 10 months to complete.
In accordance with the PDUFA (Prescription Drug User Fee Act), the FDA aims to finish the AXOL review of marketing authorization by February 2021.
CMO of Athenex, Rudolph Kwan stated that the company is actively working on priority review with the US FDA in order to offer the medication to patients suffering from metastatic breast cancer as early as possible. The firm plans to continue its investments towards expanding the reach and use of the oral drug.
The review application for Axol was submitted on the basis of outcomes of phase 3 clinical trial in comparison with the efficacy and safety monotherapy and paclitaxel monotherapy in patients diagnosed with metastatic breast cancer. The trial’s primary endpoint, objective response rate (ORR), was enhanced to a significant point in Rexol in comparison with the intravenous paclitaxel, as well as the neuropathy incidence was also relatively low.
Hanmi Pharma’s ‘ORASCOVERY’ platform technology, which transforms the anticancer drugs used for injections to be used for oral therapy was implemented for AXOL. In 2018, Rexol was given the designation of the orphan drug to treat hemangiosarcoma by the FDA. The drug was also approved by European EMA in 2019 to treat soft tissue sarcoma.
Source credit: https://www.en24news.com/2020/09/fda-designates-hanmi-pharmaceuticals-anticancer-drugorasol-for-priority-review.html