03/20/2018

Recent Oncology Related FDA Approvals/Changes

• FDA  approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. More Information.  March 20, 2018
• FDA approved abemaciclib (VERZENIO, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. More Information.  February 26, 2018 (1)

• FDA approved durvalumab (Imfinzi, AstraZeneca Inc.) for patients with unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. More Information.  February 16, 2018 (2)

• FDA approves apalutamide for non-metastatic castration-resistant prostate cancer. More Information.  February 14, 2018  (2)

• FDA approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). More Information.  February 7, 2018 (2)

• FDA approved Feraheme for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Feraheme is also indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). More Information. February 2, 2018 (2)