Web Exclusives

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.

Immune checkpoint inhibitors have changed the treatment landscape for many cancer types. These immunomodulatory antibodies target the PD-1, PD-L1, and CTLA-4 pathways to help restore immune responses against tumors.

San Francisco, CA—The immunotherapy combination of nivolumab (Opdivo) and ipilimumab (Yervoy) provides durable clinical benefit in patients with previously treated DNA mismatch repair–deficient (dMMR)/microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC).

In a January 3, 2018, statement from FDA Commissioner Scott Gottlieb, MD, the FDA announced new steps to promote generic drug competition as a way to expand potential access to inexpensive medicines, which would be especially helpful for patients with cancer. These new steps are a part of the FDA’s ongoing implementation of the Drug Competition Action Plan.