The US FDA has approved Retevmo (40 & 80mg) for LA or metastatic solid tumors with RET gene fusion. Retevmo also received the traditional approval from the US FDA for LA or metastatic NSCLC with a RET gene fusion
The 2 approvals were based on the P-I/II (LIBRETTO-001) trial for Retevmo. In RET fusion+ solid tumors, 90% received prior systemic therapy in patients with tumor-agnostic data, ORR (44%), CR (4.9%), PR (39%), m-DoR (24.5mos.) with 67% in ≥6mos. In NSCLC, ORR (84% in Retevmo vs 61% in CT), CR (5.8% vs 7.3%), PR (78% vs 54%), m-DoR (20.2 vs 28.6mos.), 50% vs 63% in ≥12mos.
In NSCLC, 5 had measurable CNS metastases, 2 with RT to the brain within 2mos., 4 patients showed responses in intracranial lesions & 38% had an intracranial DoR of ≥12mos.
Ref: PRNewswire | Image: Eli Lilly