FDA Approvals, News & Updates

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.

The US Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor afatinib (Gilotrif; Boehringer Ingelheim Pharmaceuticals) for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) who have the epidermal growth factor receptor (EGFR) gene mutations exon 19 deletions or exon 21 L858R substitution.

The FDA denied the approval of a New Drug Application for tivozanib, which was submitted by its manu­facturer (Aveo Pharmaceuticals/Astellas), for the treatment of renal-cell carcinoma.

The FDA approved lenalidomide capsules (Revlimid; Celgene Cor­poration) for the treatment of patients with mantle-cell lymphoma whose disease has relapsed or progressed after 2 previous therapies, one of which included bortezomib (Velcade). Lenalidomide is already approved for multiple myeloma (as is bortezomib).