Lilly`s Retevmo lands new accelerated approval for pediatric cancers
Eli Lilly is on a roll with its RET inhibitor Retevmo, with new trial results showing the drug can offer dramatic benefits in the treatment of certain lung and thyroid cancers.
INDIANAPOLIS, Oct. 21, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from both the LIBRETTO-431 Phase 3 study, which evaluated Retevmo® (selpercatinib) versus platinum-based chemotherapy — with or without pembrolizumab — as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), and the LIBRETTO-531 Phase 3 study, which evaluated Retevmo versus multikinase inhibitors (MKIs) in patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC). In both clinical studies, results were based on pre-specified interim efficacy analyses conducted by independent data monitoring committees (IDMC). Results from the LIBRETTO-431 and LIBRETTO-531 Phase 3 trials were presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2023 and simultaneously published in the New England Journal of Medicine.
U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Lilly’s Retevmo® (selpercatinib) for Certain Patients with Solid Tumors
INDIANAPOLIS, Aug. 22, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-531 study evaluating Retevmo versus physician's choice of the multikinase inhibitors (MKIs) cabozantinib or vandetanib as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). This result was based on a pre-specified interim efficacy analysis conducted by an independent data monitoring committee (IDMC). Adverse events observed on Retevmo were generally consistent with those identified across the previously reported Retevmo development program (LIBRETTO-001, LIBRETTO-121, LIBRETTO-321).
INDIANAPOLIS, Aug. 4, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the LIBRETTO-431 study evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed – with or without pembrolizumab – as an initial treatment for patients with rearranged during transfection (RET) fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). This result was based on a pre-specified interim efficacy analysis conducted by an independent data monitoring committee (IDMC). Adverse events observed on Retevmo were generally consistent with those identified across the previously reported Retevmo development program (LIBRETTO-001, LIBRETTO-121, LIBRETTO-321).
Eli Lilly`s Retsevmo (selpercatinib) Receives Approval in Europe
The China National Medical Products Administration (NMPA) has approved Innovent Biologics’ new drug application (NDA) for selpercatinib to treat lung and thyroid cancers.
(RTTNews) - Eli Lilly and Co. (LLY) said that the U.S. Food and Drug Administration has approved Retevmo (selpercatinib, 40 mg & 80 mg capsules) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.