Lilly receives EU Marketing Authorization for Retsevmo® as a First-Line Treatment for Advanced RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC) in Adults
Eli Lilly and Company today announced that the European Medicines Agency (EMA) has granted marketing authorisation (MA) for Retsevmo® (selpercatinib) as first-line monotherapy indicated for the treatment of adults with advanced rearranged during transfection ( RET) fusion-positive non-small cell lung cancer (NSCLC), not previously treated with a RET inhibitor. Retsevmo is a selective and potent RET kinase inhibitor with central nervous system activity that has previously been approved for treatment of adult patients with metastatic RET fusion-positive NSCLC who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
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. Results shared at the European Lung Cancer 2022 demonstrated:
Safety among patients in this cohort was consistent with the known safety profile of Retsevmo. In the safety population (all NSCLC patients that received at least one dose of Retsevmo, N=356), the most common adverse events (AEs in ≥25% of patients) were dry mouth, diarrhea, hypertension, increased ALT/AST, peripheral edema, constipation, rash, headache, and fatigue. Thirty-four patients discontinued due to an adverse event (10%), eleven (3%) of which were deemed related to Retsevmo.
A global, randomized, Phase 3 trial is currently recruiting and will compare treatment with Retsevmo to the current standard of care in the first-line treatment of advanced or metastatic RET fusion-positive NSCLC. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
Tags in this Article:
Let’s recognise obesity for what it is: a chronic disease on the rise that needs a...
As reflected in the WHO European Regional Obesity Report 2022, obesity is inflicting a profound burden on individuals, families, societies and healthcare systems across Europe. People living with the condition are struggling on a daily basis with weight management and the stigma associated with obesity.
As we emerge from the COVID-19 pandemic, what global health priorities will the G7...
The G7 holds an essential role in providing guidance on future pandemic preparation and driving improvement in our global health architecture. At Lilly, we support Germany’s programme for their G7 presidency, and welcome their ambition to tackle antimicrobial resistance.
Lilly recieves EU marketing authorisation for Abemaciclib (Verzenios®▼) as a option -...
Eli Lilly and Company announced today that the European Medicines Agency (EMA) has granted marketing authorisation (MA) for abemaciclib in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.