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Palbociclib (Ibrance Capsules)

FDA approved palbociclib (IBRANCE  Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

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IMLYGICTM (talimogene laherparepvec)

INDICATION IMLYGIC™ is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.   Limitations of use: IMLYGIC™ has not been shown to improve overall survival or have an effect on visceral metastases.   IMPORTANT SAFETY INFORMATION   Contraindications […]

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KYPROLIS® (Carfilzomib)

On January 21, 2016, the U.S. Food and Drug Administration updated the U.S. Prescribing Information for KYPROLIS® (carfilzomib) with the following indications:   KYPROLIS® (carfilzomib) is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of […]

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Fosaprepitant Dimeglumine (EMEND) New Indication

Fosaprepitant dimeglumine for injection 150 mg is now indicated in adults in combination with other antiemetic agents for the prevention of delayed nausea and vomiting associated with initial and repeat courses of MEC. The approved dosage in adults is a single 150-mg intravenous (IV) infusion over 20 to 30 minutes approximately 30 minutes prior to […]

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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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