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Nivolumab (Opdivo) for Hodgkin Lymphoma

FDA granted accelerated approval to nivolumab (Opdivo, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).

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Gilotrif (Afatinib)

FDA approves Gilotrif® (afatinib) as new oral treatment option for patients with squamous cell carcinoma of the lung. Approval provides a new second-line treatment option for patients with the second largest sub-type of non-small cell lung cancer (NSCLC), representing about 20-30% of NSCLC cases Approval is based on results of the LUX-Lung 8 study, which […]

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Lenvatinib Capsules (Lenvima)

The U. S. Food and Drug Administration approved lenvatinib capsules (Lenvima, Eisai, Inc.), in combination with everolimus, for the treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy. Lenvatinib was first approved in 2015 for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

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BiCNU (Carmustine for Injection)

FDA Alert – Counterfeit Product Discovered in Some Foreign Countries

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Cabozantinib (CABOMETYX)

On April 25, 2016, the U. S. Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

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Venetoclax (Venclexta)

The U. S. Food and Drug Administration approved venetoclax (VENCLEXTA tablets, marketed by AbbVie, Inc. and Genentech USA, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. April 11, 2016.

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Defitelio (Defibrotide Sodium)

The U. S. Food and Drug Administration approved Defitelio (defibrotide sodium, Jazz Pharmaceuticals, Inc.) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

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Xalkori (Crizotinib)

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC.

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Crizotinib Capsules (Xalkori)

U. S. Food and Drug Administration approved crizotinib capsules (Xalkori, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. March 11, 2016.

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Everolimus (Afinitor)

U.S. Food and Drug Administration approved everolimus (Afinitor, Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.

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