FDA Approvals, News & Updates

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

March 2018, Vol 8, No 3 - 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 ]

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

March 2018, Vol 8, No 3 - 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 ]

Zytiga Receives New Indication, with Prednisone, for Metastatic, High-Risk Castration-Sensitive Prostate Cancer

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates, Prostate Cancer

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. [ Read More ]

Lutathera First Radioactive Drug Approved for Adults with Gastroentero­pancreatic Neuroendocrine Tumors

March 2018, Vol 8, No 3 - 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

March 2018, Vol 8, No 3 - 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 ]

Verzenio a New CDK4/CDK6 Inhibitor Approved for Metastatic Breast Cancer

December 2017, Vol 7, No 12 - FDA Approvals, News & Updates

On September 28, 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2­negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting. [ Read More ]