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Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU(R) (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

Each year in Europe more than 550,000 patients are diagnosed with breast cancer, of whom 70% have estrogen receptor (ER)-positive disease?; more than 147,000 breast cancer patients in Europe die annually from the disease?If approved by the European
United States Giuseppe Curigliano Elcin Barker Ergun European Institute Of Oncology Stemline Therapeutics Inc Menarini Group

CHMP Advises Against Adagrasib Approval for KRAS G12C–Mutant Advanced NSCLC

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.
United States Committee For Medicinal Products Human Use European Union European Medicines Agency Medicinal Products Human Use

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