FDA Updates

1. New Molecular Entities and New Biologic License Applications
2. New Oncology Biosimilars Approved in 2018

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Melanoma is the most dangerous form of skin cancer.¹ 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. Read More ›

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. Read More ›

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. Read More ›

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), also known as carcinoids and islet-cell tumors, are tumors of the neuroendocrine cells that occur in the gastrointestinal (GI) tract. GEP-NETs are heterogeneous and complex. Although relatively rare, GEP-NETs are more common than other tumors of the GI tract, including stomach and pancreatic carcinomas combined. Read More ›

Hairy-cell leukemia (HCL) is a rare and indolent hematologic cancer. HCL, which is 4 to 5 times more frequent in men than in women, accounts for 2% of all leukemias. Approximately 1000 new cases of HCL are diagnosed in the United States annually. Read More ›

Prostate cancer, the second most common type of cancer in men, is expected to affect 11.6% of all men during their lifetime. In fact, more than 3 million men in the United States are living with prostate cancer. It is estimated that in 2017, 161,360 men were newly diagnosed with prostate cancer, and 26,730 men died from the disease. Read More ›

In 1944, Jan G. Waldenström, MD, published his observations about a series of patients who presented with anemia, hepatosplenomegaly, hyperviscosity, bleeding, lymphoplasmacytic infiltrate in the bone marrow, and a large serum protein or “macroglobulin.”¹ Today, Waldenström’s macroglobulinemia, also known as lymphoplasmacytic lymphoma, a type of non-Hodgkin lymphoma, is classified as a rare, indolent, and heterogeneous type of lymphoma of the lymphatic system. Read More ›

Conventional cytotoxic chemotherapy works primarily by interfering with the division and growth of cells, including cancer cells and normal tissue. However, because it is nonselective, cytotoxic chemotherapy can damage healthy cells and can cause severe side effects. Recognizing this challenge, drug developers have been looking for new ways to deliver chemotherapy to address clinical and pharmacologic challenges in the administration of intravenous (IV) cytotoxic drugs, and selectively target cancer cells to improve clinical outcomes and reduce severe adverse events. Read More ›

Cutaneous squamous-cell carcinoma (CSCC) is a type of nonmelanoma skin cancer that affects the squamous cells in the middle and outer layers of the skin. CSCC occurs most frequently on sun-exposed areas, such as the scalp, ears, lips, face, neck, and backs of the hands. Less often, CSCC can be in the skin of the genital area. Read More ›