Verastem (VSTM) was granted accelerated approval from the US Food and Drug Administration for the Avmapki Fakzynja Co-pack to treat patients with KRAS-mutated, recurrent low-grade serous ovarian cancer, according to a statement from the regulator.
The efficacy of the drug combination of avutometinib and defactinib was assessed in a trial of 57 adult patients who had received prior systemic therapy, the FDA said.
The overall response rate and duration of response range recorded during the trial were 44% and between 3.3 months and 31.1 months, according to a statement.
There were several common adverse reactions observed, including nausea, rash, diarrhea, edema, abdominal pain, pruritus, visual impairment, cough, and urinary tract infections, the regulator said.
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