FDA Approvals, News & Updates

On June 10, 2019, the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody–drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 lines of therapy. The FDA granted polatuzumab breakthrough therapy and orphan drug designations.

On May 28, 2019, the FDA approved lenalidomide (Revlimid; Celgene), in combination with rituximab (Rituxan), for the treatment of patients with previously treated follicular lymphoma or marginal-zone lymphoma (MZL). The FDA used its priority review program for this approval, and granted lenalidomide plus rituximab an orphan drug designation for this new indication.

On February 26, 2018, the FDA approved a new indication for abemaciclib (Verzenio; Eli Lilly), a CDK4/CDK6 inhibitor, alone or in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases.

The Lynx Group is pleased to bring you the Fourth Annual Oncology Guide to New FDA Approvals. The goal of this Guide is to offer oncologists, pharmacists, oncology nurses, and other healthcare stakeholders a comprehensive overview of new drugs approved by the US Food and Drug administration (FDA) in 2018 for the treatment of different types of cancer, including hematologic and oncologic malignancies. This practical tool offers a quick, evidence-based resource for hematology/oncology professionals to guide their medication-related decision-making and help ensure the administration of recent medicines for appropriate patients.

Melanoma is the most dangerous form of skin cancer. The 5-year relative survival rate for Americans with distant melanoma is only 23%. The National Cancer Institute estimated that there were 91,270 new cases of skin melanoma and more than 9300 deaths from this disease in 2018. This deadly disease is also costly; in the United States, expenditures for the treatment of melanoma exceeded $3 billion in 2018.

Chronic lymphocytic leukemia (CLL) is a cancer of B-cell lymphocytes and is the most common type of leukemia in adults. More than 20,000 Americans were diagnosed with CLL in 2018.

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow that is characterized by the production of abnormal myeloblasts, red blood cells, or platelets. AML originates in the bone marrow, but it often spreads into the blood and to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system.