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Ixazomib (Ninlaro)

On November 20, 2015, the U.S. Food and Drug Administration approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.  Ixazomib is the first approved oral proteasome inhibitor. […]

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Nivolumab (Opdivo Injection)

On November 23, 2015, the U. S. Food and Drug Administration approved nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf

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Necitumumab (Portrazza)

On November 24, 2015, the U.S. Food and Drug Administration granted approval to necitumumab (PORTRAZZA, Eli Lilly and Company) in combination with gemcitabine and cisplatin for first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Necitumumab is not indicated for treatment of non-squamous NSCLC. Full prescribing information is available:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf

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Elotuzumab (Empliciti)

On November 30, 2015, the U. S. Food and Drug Administration approved elotuzumab (EMPLICITI, Bristol-Myers Squibb Company) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Full prescribing information is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761035s000lbl.pdf

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BENDEKA (bendamustine hydrochloride)

FDA approval alert: new drug approved for treatment of CLL and non-hodgkin lymphoma BENDEKA (bendamustine hydrochloride) injection has been approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen. The drug, which […]

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Eribulin (Halaven Injection)

FDA approved eribulin (HALAVEN injection, Eisai Co., Ltd.) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.  January 28, 2016.

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Ofatumumab (Arzerra Injection)

FDA approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate […]

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Pembrolizumab (Keytruda Injection) Label Updated

On December 18, 2015, the U. S. Food and Drug Administration (FDA) expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or metastatic melanoma. This expansion now includes the initial treatment of patients with unresectable or metastatic melanoma with pembrolizumab.

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Alectinib (Alecensa)

On December 11, 2015, the U. S. Food and Drug Administration granted accelerated approval to alectinib (ALECENSA capsules, Hoffmann-La Roche Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

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