In the News

On January 12, 2014, the FDA approved a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 previous therapy, using the agency’s accelerated approval process.
On April 17, 2014, the FDA approved ofatumumab (Arzerra Injection; Glaxo­SmithKline), in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
On April 21, 2014, the FDA approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastro­esophageal junction adenocarcinoma.
On April 29, 2014, the FDA approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC).
On May 28, 2014, the FDA approved a new indication for palonosetron HCl (Aloxi; Eisai) injection for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) associated with initial or repeated courses of emetogenic chemotherapy in children aged 1 month to
On July 3, 2014, the FDA approved belinostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).
On July 23, 2014, the FDA approved idelalisib (Zydelig; Gilead Sciences) for the treatment of patients with relapsed CLL to be used in combination with rituximab.
A few days after the approval of the combination of the 2 melanoma drugs, the FDA approved dabrafenib (Tafinlar) as a breakthrough therapy designation for lung cancer based on interim results from an ongoing phase 2 clinical trial.
The FDA approved a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 therapy before. The approval was granted under the FDA’s accelerated approval process to expedite access by patients with CLL to this promising new medication.
Transparent and comprehensive reporting of adverse events (AEs) in published results of oncology-related clinical trials is crucial for the treatment of patients with cancer.
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