FDA Approvals, News & Updates

The US Food and Drug Administration (FDA) approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, which mostly affects older adults.

The US Food and Drug Administration approved ofatumumab (Arzerra Injection, GlaxoSmithKline) in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia, for whom fludarabine-based therapy is considered inappropriate.

The US Food and Drug Admin­istration (FDA) approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC). Ceritinib is an ALK tyrosine kinase inhibitor that blocks proteins that promote cancer cell growth. The drug is approved for the treatment of patients with late-stage NSCLC who were previously treated with crizotinib, the first and only other ALK tyrosine kinase inhibitor approved by the FDA.

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 1therapy before.

>The US Food and Drug Administration (FDA) approved the use of dabrafenib (Tafinlar; GlaxoSmithKline) plus trametinib (Mekinist; GlaxoSmithKline) as a new combination therapy for the treatment of patients with advanced melanoma that is unresectable or metastatic.

A few days after the first drug with a breakthrough therapy designation was approved by the US Food and Drug Administration (FDA), ibrutinib (Imbruvica; Pharmacyclics/Janssen Biotech)—the second drug with such a designation—received an accelerated FDA approval for the treatment of patients with mantle-cell lymphoma (MCL), a rare form of non-Hodgkin lymphoma (NHL). MCL represents approximately 6% of all cases of NHL in the United States.

Using its priority review pathway, the US Food and Drug Administration (FDA) approved the monoclonal antibody obinutuzumab (Gazyva; Genentech) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not previously received treatment for CLL. Obinutuzumab is approved to be used in combination with chlorambucil.

The US Food and Drug Administration (FDA) granted accelerated approval to pertuzumab (Perjeta; Genentech) as part of a treatment regimen for the neoadjuvant setting (ie, before surgery) for patients with HER2-positive early-stage breast cancer. This is the first time that the FDA approved a drug for the neoadjuvant treatment of patients with breast cancer.

The US Food and Drug Administra­tion (FDA) approved a new indication for paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane; Celgene) for the treatment of patients with metastatic pancreatic cancer.