News

Nivolumab (Opdivo Injection)

Posted on 2.8.2016

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: … Read More

Necitumumab (Portrazza)

Posted on 2.8.2016

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 … Read More

Elotuzumab (Empliciti)

Posted on 2.8.2016

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 … Read More

BENDEKA (bendamustine hydrochloride)

Posted on 2.8.2016
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 … Read More

Eribulin (Halaven Injection)

Posted on 2.1.2016

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.… Read More

Ofatumumab (Arzerra Injection)

Posted on 1.20.2016

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 … Read More

Pembrolizumab (Keytruda Injection) Label Updated

Posted on 1.7.2016

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 … Read More

Alectinib (Alecensa)

Posted on 1.7.2016

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 … Read More