In the News

FDA Approves Pembrolizumab for Treatment of Advanced Melanoma

On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first [ Read More ]

FDA Approves Split-Dosing Regimen for Daratumumab in Patients with Multiple Myeloma

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients [ Read More ]

February 8, 2019 – FDA Approvals, News & Updates

This week, the US Food and Drug Administration (FDA) approved a new drug for a rare blood clotting disorder and alerted healthcare providers to a cancer risk associated with breast implants. In This Article FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder [ Read More ]

February 1, 2019 – FDA Approvals, News & Updates

In This Article FDA Resumes Operations After Government Shutdown Ends FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma FDA Approves Pembrolizumab for Merkel-Cell Carcinoma FDA Resumes Operations After Government Shutdown Ends On Saturday, January 26, 2019, the US Food and Drug Administration (FDA) issued a statement advising all [ Read More ]

Government Shutdown Impacts FDA Drug Approvals

Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, [ Read More ]

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 ]