The Food and Drug Administration has granted accelerated approval to Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets), made by Verastem Oncology, making it the first FDA-approved treatment for patients with recurrent low-grade serous ovarian cancer (LGSOC) who have a KRAS mutation.
The approval is based on the results of the Phase 2 RAMP 201 clinical trial, which evaluated this oral combination therapy in 57 adult patients with measurable KRAS-mutated recurrent LGSOC. The findings, as assessed by a blinded independent review committee, show a 44% overall response rate to the treatment. Approved therapeutic use is for adult patients who have received prior treatment for LGSOC.
“Low-grade serous ovarian cancer is a rare and highly recurrent cancer with limited effective treatment options,” said OCRA grantee Rachel Grisham, MD, Section Head, Ovarian Cancer at Memorial Sloan Kettering Cancer Center and Global Lead Principal Investigator of the confirmatory Phase 3 trial, GOG-3097/ENGOT-ov81/GTG-UK/RAMP 301.
The approval of avutometinib plus defactinib brings a much-needed therapeutic option to patients and establishes this combination as the new standard of care for women with recurrent low-grade serous ovarian cancer harboring a KRAS mutation.
Dr. Rachel Grisham is a recipient of OCRA’s 2014 Early Career Investigator Grant. Research supported by OCRA and involving Dr. Grisham led to important breakthroughs published in 2015 and 2023.
