FDA nod for first-ever treatment for LGSOC, a rare cancer

The US Food and Drug Administration (FDA) has approved Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy, Boston, said USA-based. Verastem Oncology (Nasdaq: VSTM), whose shares rose 3.7% to $6.94 on the news.

Avmapki Fakzynja Co-pack is the first and only FDA-approved medicine for this disease. This indication is approved under accelerated approval based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Avmapki Fakzynja is only commercially available in the USA as an oral combination co-pack with the two prescription products, known as Avmapki Fakzynja Co-pack”

“Today’s approval of Avmapki Fakzynja Co-pack for patients with KRAS-mutated recurrent low-grade serous ovarian cancer represents not only the first-ever FDA-approved treatment specifically for this rare cancer but also a new day for people living with this disease who have been in desperate need of new treatment options,” said Dan Paterson, president and chief executive of Verastem Oncology. “We are very proud to bring two innovative medicines in one combination treatment to the LGSOC community. We thank the researchers, patients, and their families participating in our clinical trials, the patient advocacy community, the FDA, and everyone at Verastem for their dedication and commitment to helping us bring Avmapki Fakzynja Co-pack to patients in the US,” he added.