FDA Approval Alert: The Need-to-Know | Avutometinib/Defactinib in KRAS+ Low-Grade Serous Ovarian Cancer

In May 2025, the FDA gave accelerated approval to avutometinib in combination with defactinib as a treatment for adult patients with recurrent, KRAS-mutated, low-grade serous ovarian cancer.

Approximately 10% of patients discontinued treatment with avutometinib/defactinib due to toxicity in the phase 2 RAMP 201 trial.
Avutometinib/Defactinib Appears Tolerable in KRAS-Mutant LGSOC
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May 16, 2025 8:00 PM
Approximately 10% of patients discontinued treatment with avutometinib/defactinib due to toxicity in the phase 2 RAMP 201 trial.
Response rates appeared to be higher with avutometinib plus defactinib vs avutometinib alone in the phase 2 RAMP 201 study.
RAMP 201 Shows “Impressive” Data in KRAS+ Low-Grade Serous Ovarian Cancer
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May 15, 2025 8:00 PM
Response rates appeared to be higher with avutometinib plus defactinib vs avutometinib alone in the phase 2 RAMP 201 study.
Patients who respond to avutometinib/defactinib may be maintained on treatment for long periods of time, says Rachel N. Grisham, MD.
Avutometinib Combo Approval Signals “Exciting Time” in KRAS-Mutated LGSOC
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May 14, 2025 10:00 PM
Patients who respond to avutometinib/defactinib may be maintained on treatment for long periods of time, says Rachel N. Grisham, MD.
Findings from the phase 2 RAMP 201 trial support the FDA approval of avutometinib plus defactinib in low-grade serous ovarian cancer.
FDA Grants Accelerated Approval to Avutometinib/Defactinib in KRAS+ LGSOC
Article
May 8, 2025 4:17 PM
Findings from the phase 2 RAMP 201 trial support the FDA approval of avutometinib plus defactinib in low-grade serous ovarian cancer.