New US-Korea Acute Myeloid Leukemia Drug Designated for FDA Fast Track

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical's acute myeloid leukemia (AML) new drug 'HM43239' has been designated as a Fast Track development item by the U.S. Food and Drug Administration (FDA).

Hanmi Pharmaceutical's partner, Aptose, announced on the 4th that HM43239 has been designated as an FDA Fast Track. Aptose explained, "The FDA recognized the potential of HM43239 to meet the unmet needs of AML patient groups." HM43239 was licensed out to Aptose in November of last year.

The Fast Track designation is one of the drug development acceleration procedures implemented by the FDA to provide early access to important new drugs for patients. Once designated as Fast Track, the drug development process is expedited through full support from the FDA at each development stage and consultations with the FDA. Additionally, benefits such as 'Rolling Review' are granted, and discussions for 'Priority Review' with the FDA can also take place.

HM43239 is a once-daily oral myeloid kinase inhibitor (MKI) targeting key kinases acting in myeloid malignant tumors. In ongoing global Phase 1 and 2 clinical trials, HM43239 has shown complete remission (CR) responses in various relapsed or refractory AML patients. Effectiveness was also confirmed in patients who participated in the trials after failing treatment with previously approved FLT3 inhibitors.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "HM43239 is a powerful hematologic cancer treatment that targets mutations expressed in AML and can overcome resistance to existing therapies," adding, "We will work closely with Aptose to accelerate development and do our best to commercialize it early."