FDA Approvals, News & Updates

The FDA’s Oncologic Drug Advisory Committee (ODAC) reviewed necitumumab (Eli Lilly & Co) for use in patients with metastatic squamous non–small-cell lung cancer (NSCLC). Necitumumab is an immunoglobulin G1 monoclonal antibody that inhibits the interaction between the human epidermal growth factor receptor (EGFR) and its ligands. EGFR expression is elevated in NSCLC and affects >95% of squamous NSCLC tumors.

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).