Value-Based Cancer Care Web Exclusives

July 2018

Erleada First Therapy Approved for Patients with Nonmetastatic Castration-Resistant Prostate Cancer

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. [ Read More ]

Stem-Cell Transplant in Multiple Myeloma Associated with Increased Healthcare Utilization and Costs

Chase Doyle

Leukemia, Multiple Myeloma

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. [ Read More ]

Tagrisso Now Approved as First-Line Therapy for Patients with Metastatic NSCLC and EGFR Mutations

FDA Approvals, News & Updates

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. [ Read More ]

Adcetris Approved as Initial Treatment for Stage III or IV Classical Hodgkin Lymphoma

FDA Approvals, News & Updates

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. [ Read More ]

Imfinzi First Treatment Approved to Reduce Disease Progression in Unresectable Stage III NSCLC After Chemoradiation

FDA Approvals, News & Updates

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. [ Read More ]

Lutathera First Radioactive Drug Approved for Adults with Gastroentero­pancreatic Neuroendocrine Tumors

FDA Approvals, News & Updates

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. [ Read More ]

Gilotrif Receives New Indication as First-Line Treatment for Metastatic NSCLC with Nonresistant EGFR Mutations

FDA Approvals, News & Updates

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. [ Read More ]

Expert Panel Tackles Merits of End Points in Castrate-Resistant Prostate Cancer: Impact on Treatment and Coverage Decisions

Wayne Kuznar

AVBCC Special Feature, Prostate Cancer

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. [ Read More ]