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Eli Lilly's Retevmo (selpercatinib) Receives the US FDA’s Approval for Advanced or Metastatic Solid Tumors with a RET Gene Fusion

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Eli Lilly's Retevmo (selpercatinib) Receives the US FDA’s Approval for Advanced or Metastatic Solid Tumors with a RET Gene Fusion

Eli Lilly's Retevmo (selpercatinib) Receives the US FDA’s Approval for Advanced or Metastatic Solid Tumors with a RET Gene Fusion

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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