Articles

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.

Chimeric antigen receptor (CAR) T-cell therapy has had excellent results in late-stage leukemia and varying degrees of success in some other hematologic cancers, but thus far, solid tumors have not responded to this therapy.

Orlando, FL—The 2018 National Comprehensive Cancer Network (NCCN) updated guideline on the management of multiple myeloma assigns preferred status to certain treatment regimens, and designates others as recommended or useful in certain circumstances.

PD-1 and PD-L1 expression on tumor cells is decidedly unique compared with other biomarkers currently used in oncology, and its use has been demonstrated in numerous clinical scenarios. But although the benefits associated with PD-1/PD-L1 targeted therapies have been unprecedented, the risks should not be underestimated.

Atlanta, GA—A recent analysis of US administrative claims data showed that stem-cell transplantation (SCT) is associated with increased healthcare resource utilization and costs compared with matched controls. According to data presented at 2017 ASH, patients who underwent SCT had, on average, >$114,000 increase in healthcare costs compared with age-, sex-, and comorbidity-matched patients with multiple myeloma who did not undergo SCT.

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.