FDA Approvals, News & Updates

March 08, 2019 – FDA Approvals, News & Updates

Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.

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

On November 24, 2015, the FDA approved Portrazza (necitumumab) in combination with 2 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 cancer death [ Read More ]

FDA Approves Opdivo to Treat Advanced Form of Kidney Cancer

On November 23, 2015, the FDA 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, MD, Director of [ Read More ]

First Anti–PD-1 Immunotherapy, Pembrolizumab, Receives Accelerated FDA Approval for Advanced Melanoma

On September 4, 2014, the FDA has approved pembrolizumab (Keytruda; Merck), the first anti–programmed death-1 (PD-1) therapy for the treatment of patients with advanced (ie, unresectable or metastatic) melanoma and disease progression after therapy with ipilimumab, or, for a patient with a BRAF V600 mutation, after ipilimumab plus BRAF inhibitor [ Read More ]

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