ABION's Vabametkib Designated as a Developmental-Stage Orphan Drug by MFDS

ABION announced on August 18 that its non-small cell lung cancer (NSCLC) treatment, Vabametkib (ABN401), has been designated as a developmental-stage orphan drug by the Ministry of Food and Drug Safety (MFDS).

The MFDS orphan drug designation system is designed to support the rapid development and approval of treatments for rare, intractable, or life-threatening diseases. With this designation, the company is expected to benefit from various forms of support, such as simplified documentation requirements during the approval review process.

Vabametkib is a targeted anticancer therapy under development for patients with advanced or metastatic NSCLC who have a MET exon 14 skipping alteration in the mesenchymal-epithelial transition (MET) gene. Currently, Vabametkib is undergoing a Phase 2 clinical trial, which includes both monotherapy and combination therapy arms.

According to the clinical results submitted for this orphan drug designation, the Vabametkib monotherapy group demonstrated an overall objective response rate (ORR) of 45%, and approximately 50% response rate among patients who received the drug after first-line treatment, positioning it as a competitive treatment option. Notably, as the clinical trial is still ongoing, further improved results are anticipated in the future.

A company representative stated, "The designation of Vabametkib as a developmental-stage orphan drug validates its potential and therapeutic value," adding, "We will expedite all clinical and regulatory processes to provide better treatment options for patients with non-small cell lung cancer." End.