In the News

FDA Approves Portrazza to Treat Advanced Squamous Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.             Lung cancer is the leading cause of [ Read More ]

FDA Approves Opdivo to Treat Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director [ Read More ]

FDA Approves Ninlaro, New Oral Medication to Treat Multiple Myeloma

Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white [ Read More ]

FDA Approves New Pill to Treat Certain Patients with Non—Small-Cell Lung Cancer

New diagnostic test identifies specific gene mutation targeted by new drug Today, the US Food and Drug Administration (FDA) granted accelerated approval for an oral medication to treat patients with advanced non—small-cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor [ Read More ]

FDA Approves Cotellic as Part of Combination Treatment for Advanced Melanoma

The US Food and Drug Administration (FDA) today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K [ Read More ]

FDA Approves First-of-Its-Kind Product for the Treatment of Melanoma

The US Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult [ Read More ]

Keytruda FDA Approved in Patients with Advanced Lung Cancer

The US Food and Drug Administration (FDA) granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non–small-cell lung cancer (NSCLC) whose disease has progressed after other treatments, and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 [ Read More ]

Nivolumab in Combination with Ipilimumab

On September 30, 2015, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type, unresectable or metastatic melanoma. Approval was based on demonstration of an increase in the objective response [ Read More ]