Articles

Nearly 12% of American men will be diagnosed with prostate cancer at some point during their lives. Prostate cancer may remain indolent, but it often requires treatment, as evidenced by the more than 26,000 deaths attributable to this disease annually. Although the 5-year survival is high for men with localized prostate cancer, this drops to 29% in men with metastatic prostate cancer. Even with treatment, prostate cancer progresses in more than 33% of men. The median time to metastatic disease is approximately 8 to 10 years after the detection of biochemical recurrence.

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.

On April 6, 2018, rucaparib (Rubraca; Clovis Oncology), a poly (ADP-ribose) polymerase (PARP) inhibitor, received a new indication by the FDA for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who achieved complete or partial response with platinum-based chemotherapy.

On April 18, 2018, the FDA approved osimertinib (Tagrisso; AstraZeneca Pharmaceuticals) as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA used its priority review process, and designated osimertinib as a breakthrough therapy for this indication.