FDA Approves Doublet for KRAS-Mutated, Recurrent, Low-Grade Serous Ovarian Cancer

1. FDA accelerated approval granted to avutometinib and defactinib combination for KRAS-mutated, recurrent, low-grade serous ovarian cancer. 2. Efficacy and dosing evaluated in RAMP 201 trial for adults with measurable KRAS-mutated recurrent LGSOC. 3. Confirmed overall response rate was 44% with a duration of response ranging from 3.3 to 31.1 months. 4. Recommended avutometinib dose is 3.2 mg orally twice weekly, and defactinib dose is 200 mg orally twice daily for the first 3 weeks of each 4-week cycle. 5. Most common adverse reactions include increased creatine phosphokinase, nausea, fatigue, rash, and musculoskeletal pain.