FDA Approvals, News & Updates

On February 14, 2018, apalu­tamide (Erleada; Janssen Pharmaceuticals), an androgen receptor inhibitor, received accelerated approval by the FDA for the treatment of patients with nonmetastatic, cas­tration-resistant prostate cancer (CRPC). Apalutamide is the first treatment approved by the FDA for patients with nonmetastatic CRPC, and was approved under the FDA priority review process.

On January 12, 2018, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca) for the treatment of women with deleterious or suspected deleterious germline BRCA-positive, HER2-negative, metastatic breast cancer who received previous chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.

On January 12, 2018, afatinib (Gilotrif; Boehringer Ingelheim) received FDA approval as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) associated with nonresistant EGFR mutations as identified via an FDA-approved test. Afatinib received orphan drug status for this indication, and was approved under the FDA priority review process.

On January 26, 2018, the FDA approved lutetium Lu 177 dotatate (Lutathera; Advanced Accelerator Applications), a radioactive drug, for the treatment of adults with somato­statin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutetium Lu 177 dotatate was approved under the FDA’s priority review process, and was designated as an orphan drug.

On February 7, 2018, abiraterone acetate (Zytiga; Janssen Biotech) received FDA approval for use, in combination with prednisone, for the treatment of patients with metastatic, high-risk castration-sensitive prostate cancer (CSPC). The FDA approved this new indication under its priority review program.

On February 16, 2018, the FDA approved an expanded indication for durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of patients with unresectable stage III non–small-cell lung cancer (NSCLC) that did not progress after chemoradiation. Durvalumab received accelerated approval in 2017 for the treatment of certain patients with metastatic or locally advanced bladder cancer.

On March 20, 2018, the FDA approved a new indication for brentuximab vedotin (Adcetris; Seattle Genetics) as a first-line treatment, in combination with chemotherapy, for adults with untreated stage III or stage IV classical Hodgkin lymphoma. The FDA approved this indication using its priority review process and designated brentuximab vedotin as a breakthrough therapy.

On March 29, 2018, the FDA accelerated the approval of a new indication for blinatumomab (Blincyto; Amgen) for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) whose disease was in remission but was at risk for relapse because of minimal residual disease (MRD). The FDA granted blinatumomab orphan drug status for this indication.