Hanmi Pharm’s oral anticancer drug’Oraxol’, which was expected to receive marketing approval from the US Food and Drug Administration (FDA) this year, received a request for supplementation, causing a disruption in the approval schedule.
According to Hanmi Pharmaceutical and Artenex, on the 1st of this month (local time), the US partner Artenex received a supplementary request letter (CRL) from the FDA for the marketing approval of the new oral anticancer drug’Oraxol’ with metastatic breast cancer as an indication. .
The FDA raised that there is a concern about the sequelae of neutropenia compared to intravenous injection when administering the oral roxol, and the uncertainty of the objective response rate (ORR) result, the primary evaluation variable evaluated by the Independent Central Review Committee (BICR) at Week 19 Expressed concern.
In addition, the FDA advised Artenex to conduct appropriate new clinical trials in patients with metastatic breast cancer in the United States to evaluate additional safety data. He also noted that additional strategies to improve safety, such as optimizing dosage, are needed.
Accordingly, Artenex plans to discuss the FDA’s requirements for clinical trial design and scope, and to request a meeting with the FDA for coordination of marketing approval approval as the next step.
Artenex said, “We are very sorry for the FDA’s decision,” and said, “We will find the best way to obtain marketing approval of recreational sol.”
Rexol is a treatment that converts the intravenous anticancer drug’paclitaxel’ to oral use by applying Hanmi Pharmaceutical’s platform technology’ORASCOVERY’, and Hanmi Pharm transferred its technology to Atenex in December 2011. did. Laxol was designated as a priority review by the FDA in September of last year, and raised expectations for success in commercialization this year.
Until now, Hanmi Pharm has revealed that’Oraxol’, a new oral anticancer drug developed by its company, showed superior effects compared to intravenous anticancer drugs in a phase 3 clinical trial.
Athenex, a partner of Hanmi Pharmaceutical, presented additional data for phase 3 clinical trials at the spotlight session of the San Antonio Breast Cancer Society (SABCS) last December.
In this presentation, Artenex increased the median PFS (progression-free survival) value to 8.4 months compared to intravenous therapy (7.4 months) in the intent-to-treat population (ITT) including a total of 402 randomized patients. The median survival) was also 23.3 months, which was 7 months longer than intravenous therapy (16.3 months).
In this regard, Hanmi Pharm and Artenex believe that AXOL has proven clinical usefulness and convenience compared to injection therapy.
However, contrary to expectations, the licensing of the recreational brush will be disrupted, and the technology export revenue that Hanmi Pharmaceutical will receive will also be delayed.
When Axol gets marketing approval from the FDA, Hanmi Pharmaceutical will receive a milestone of 24 million dollars (about 28.4 billion won) from Artenex and royalties based on net sales.
In August of last year, Artenex succeeded in attracting an investment of 50 million dollars (approximately 59.2 billion won) from’Gagad Healthcare Loyalty Partners’, a Canadian healthcare professional asset management company. This is for commercialization of Axol, and financing between Artenex and Sagard is established only when Axol obtains marketing approval from the FDA.
Hanmi Pharm has not been informed of the availability and timing of additional clinical trials from Artenex.
An official of Hanmi Pharmaceutical said, “Athenex will hold a meeting with the FDA on the issue of the supplemental request raised by the FDA.” .