Chugai And Verastem Achieve First FDA Approval For LGSOC With AVMAPKI Combination Therapy

Chugai Pharmaceutical announced that Verastem Oncology has received FDA accelerated approval for AVMAPKI™ FAKZYNJA™ CO-PACK, an oral combination therapy of avutometinib and defactinib, for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have previously undergone systemic treatment. 

The approval is based on tumour response rates and duration of response observed in clinical trials. As an accelerated approval, continued FDA endorsement will depend on confirmatory trials that demonstrate sustained clinical benefit. The treatment is only commercially available in the U.S. as a combination pack containing the two drugs, branded jointly as AVMAPKI FAKZYNJA CO-PACK. 

The VAMAPIKI product was first developed by Chugai Pharma and is further explored in the clinical setting with Verastem Oncology. This achievement makes AVMAPKI the 7th Chugai-derived medicine to have been granted global regulatory approval.