FDA Approvals, News & Updates

FDA Approves New Combination Therapy, Akynzeo, for the Prevention of Nausea and Vomiting Associated with Chemotherapy
FDA Grants Priority Review for Palbociclib, a Novel Breast Cancer Drug

The FDA approved the first anti–programmed death receptor-1 (PD-1) therapy, pembrolizumab (Keytruda; Merck), for patients with unresectable or metastatic melanoma and disease progression after treatment with other melanoma therapy, such as ipilimumab, or, for a patient with BRAF V600 mutation, after BRAF inhibitor therapy.

The FDA issued an expanded indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with CLL who have a deletion in chromosome 17 (17p deletion), which results in poor response to standard CLL therapies.

The FDA approved idelalisib (Zydelig; Gilead Sciences) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) to be used in combination with rituximab (Rituxan).

The FDA approved belinostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

Palonosetron HCl (Aloxi; Eisai) injection received a new US Food and Drug Administration (FDA) indication 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