FDA Grants Priority Review to Polatuzumab Vedotin Combination for R/R DLBC
February 19th 2019The FDA granted a priority review to polatuzumab vedotin in combination with bendamustine plus rituximab (Rituxan) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
FDA Grants Priority Review to Entrectinib for NTRK+ Solid Tumors, ROS1+ NSCLC
February 19th 2019The FDA granted a priority review to entrectinib for the treatment of adult and pediatric patients with NTRK fusion-positive, locally advanced or metastatic solid tumors and for metastatic, ROS1-positive non-small cell lung cancer.
FDA Grants Priority Review to Frontline Pembro to Treat Recurrent, Metastatic HNSCC
February 11th 2019The FDA granted a priority review to the supplemental biologics license application for pembrolizumab (Keytruda) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
FDA Expands Pemetrexed Approval for Frontline Pembrolizumab/Chemo Combo in NSCLC
January 31st 2019The FDA has expanded the indication for pemetrexed (Alimta) injection in combination with pembrolizumab (Keytruda) and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK alterations.