FDA Approves Libtayo as Monotherapy for Advanced NSCLC

Libtayo | Lung CancerLung cancer is one of the leading causes of cancer-related deaths worldwide. In the year 2020, an estimated 225,000 new cases were diagnosed in the United States. Also, approximately 84% of all lung cancers are NSCLC, with 75% diagnosed in advanced stages and about 25%-30% expected to test positive in PD-L1 in 50% or more of tumor cells. FDA has approved Libtayo as a monotherapy treatment for non-small cell lung cancer with a programmed death-ligand 1 (PD-1) expression of 50% or more.

This is the first approval for Libtayo after it received approval as the first immunotherapy indicated for patients with advanced basel cell carcinoma and it was approved as first systemic treatment for adults with advanced cutaneous squamous cell carcinoma. The data supporting this approval is based on an analysis of 710 patients who were randomized to receive treatment in phase 3 trial. In this patient population, Libtayo reduced the death risk by 32% compared to chemotherapy. Due to PD-L1 testing issues, additional pre-specified analysis was performed in 563 patients with proven PD-L1 expression of over 50%. This analysis showed that Libtayo reduced death risk by 43% compared to chemotherapy.

Non-Small-Cell Lung Cancer (NSCLC)Naiyer Rizvi, MD, director of thoracic oncology and co-director of cancer immunotherapy at Columbia University Irving Medical Center, said, “The approval of Libtayo to treat first-line advanced non-small lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease.”

This approval follows a Priority Review by the FDA which is reserved for medicines that represent significant improvement in safety in treatment of serious conditions. The need for additional therapeutic options in advanced non-small cell lung cancer is clear. Libtayo allows physicians to further optimize treatment of such patients who tumors have high expression of PD-L1.


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