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Lurbinectedin Maintenance Combo Earns FDA Priority Review in ES-SCLC
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7 Articles
PharmaMar Rises 6% After Obtaining 'Priority Review' From the US to Combine Two Drugs in Lung Cancer
PharmaMar's shares rose by more than 6% in the Continuo Market, the index in which it is listed, until it was exchanged at a unit price of €90.85 at 1.30 p.m., after announcing that the US Food and Drug Administration (FDA) has approved the priority review, 'Priority Review', for the combination of two of its medicines, Zepzelca (Lurbinectedine) and atezolizumab (Tecentriq) for advanced small cell lung cancer.
Lurbinectedin and Atezolizumab Combo Demonstrates Survival Benefit in ES-SCLC - ILCN.org (ILCN/WCLC)
Luis G. Paz-Ares, MD, PhD, took the stage on Monday, June 2, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to present findings from the phase III IMforte trial, which evaluated lurbinectedin in combination with atezolizumab as maintenance therapy for patients with extensive-stage small cell lung cancer (ES-SCLC). Dr. Paz-Arez, the study’s lead author, said the latest data indicate that some patients experienced improved…
The FDA's approval of a priority review is allocated to applications for medicines that offer a significant improvement in the safety or efficacy of the treatment of a serious disease, the company has specified. In addition, it has said that the FDA aims to make a decision on the application for registration of a new drug (NDA) within six months (compared to the ten months of the standard review). FDA has set the deadline for issuing its decisio…
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