Lilly Receives EU Marketing Authorisation for Retsevmo® as a First-Line Treatment for RET-Mutant Medullary Thyroid Cancer (MTC) in Adults and Adolescents 12 Years and Older
Eli Lilly and Company today announced that the European Medicines Agency (EMA) has granted marketing authorisation (MA) for Retsevmo® (selpercatinib 40 mg & 80 mg oral capsules) as a first-line monotherapy indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer. Selpercatinib is a selective and potent RET kinase inhibitor with central nervous system activity that has previously been approved for the treatment of advanced medullary thyroid cancer in patients aged 12 years and older who had previously been treated with the cancer medicines cabozantinib or vandetanib or both. RET mutations in people with advanced medullary thyroid cancer are associated with more aggressive disease and poorer outcomes for patients.[1]
This approval is based on the Phase 1/2 LIBRETTO-001 trial, which is the largest clinical trial of patients with RET-driven cancers treated with a RET inhibitor. LIBRETTO-001 is a multi-centre (16 countries, 89 sites), open-label, single-arm clinical study and included a Phase 1 dose escalation and Phase 2 dose expansion. The primary efficacy outcome measure of the Phase 2 was overall response rate (ORR) according to RECIST v1.1 as evaluated by a blinded independent review committee (IRC). Secondary efficacy outcomes included duration of response (DOR), progression free survival (PFS) and overall survival (OS). Results demonstrated:
Abbreviations: n. number of patients; NE, not estimable; CI, confidence intervals
In the safety population (all LIBRETTO-001 patients that received at least one dose of selpercatinib, N=796), the most common serious adverse events were abdominal pain (2.5%), hypersensitivity (2.0%), diarrhoea (1.9%), alanine aminotransferase (ALT) increased (1.5%) and aspartate aminotransferase (AST) increased (1.5%). Eight percent of patients were discontinued due to an adverse event regardless of attribution.
Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
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Lilly unites caring with discovery to create medicines that make life better for people around the world. We’ve been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer’s disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
[1] National Institute for Health and Care Excellence (NICE). Selpercatinib for treating advanced thyroid cancer with RET alterations. Technology Appraisal Guidance (TA742) published November 2021. https://www.nice.org.uk/guidance/ta742/chapter/3-Committee-discussion Last accessed 12 September 2022.
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