Posted from: Monday, December 28, 2015 - 10:53 AM - Present

New Indications Approved for Opdivo

November 23, 2015 – The U.S. Food and Drug Administration (FDA) approved Opdivo to treat metastatic renal cell carcinoma (RCC) for patients who have had prior treatment with an angiogenesis inhibitor, such as Nexavar (sorafenib – Bayer). In a clinical study of RCC patients, overall survival for those treated with Opdivo was about five months longer than for study participants receiving a different type of renal cancer drug. Then on November 24, 2015, the FDA also approved Opdivo as a first-line monotherapy for treating patients with inoperable or metastatic BRAF V600 wild-type melanoma. In the clinical study of Opdivo versus chemotherapy for this indication, overall survival for patients in the Opdivo group was about five months as compared to a little over two months for patients on chemotherapy. Opdivo (nivolumab) injection is a human programmed death receptor-1 (PD-1) immune checkpoint inhibitor, manufactured by Bristol-Myers Squibb, first approved by FDA in December 2014. It enhances immune response by blocking specific receptors that deactivate immune cells. Previously, it has been FDA approved for treating progressed melanoma after treatment with Yervoy and a BRAF inhibitor, for second-line, single-agent therapy for advanced squamous and non-squamous-cell non-small cell lung cancer (NSCLC) following chemotherapy with a platinum-based drug and, in combination with Yervoy (ipilimumab – Bristol-Myers Squibb), for treating malignant melanoma. Opdivo’s dosing for both new indications is 3mg/kg of body weight given as an intravenous (IV) infusion once every two weeks until the cancer worsens or side effects become too severe.


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