2019 Fourth Annual Oncology Guide to New FDA Approvals
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.
- Oncology Overview
- Breast Cancer New Indications
- Genitourinary Cancers New Indications
- Gynecologic Cancers New Indications
- Hematologic Malignancies New Indications
- Lung Cancer New Indications
- Other Tumor Types New Indications
- New Molecular Entities and New Biologic License Applications
- New Oncology Biosimilars Approved in 2018
Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation
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.
Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy
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.
Erleada (Apalutamide) First Drug Approved by the FDA for Nonmetastatic Castration-Resistant Prostate Cancer
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.
Imbruvica (Ibrutinib) plus Rituxan (Rituximab) New Combination Approved for the Treatment of Waldenström’s Macroglobulinemia
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.” 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
Infugem (Gemcitabine) First Formulation of Premixed, Ready-to-Administer Intravenous Chemotherapy Approved for Several Tumor Types
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.
Libtayo (Cemiplimab-rwlc), a PD-1 Inhibitor, First Drug Approved by the FDA for Patients with Advanced Cutaneous Squamous-Cell Carcinoma
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.
Lorbrena (Lorlatinib) Approved for the Treatment of Metastatic Non–Small-Cell Lung Cancer with ALK Mutation
Lung and bronchus cancer, the second most common form of cancer, accounts for 13.5% of all new cancer cases in the United States. In 2018 alone, lung cancer was newly diagnosed in 234,030 individuals and accounted for 154,050 deaths. In fact, lung cancer is the leading cause of cancer-related mortality in men and women, and is responsible for more than 25% of all cancer deaths. The 5-year survival rate for patients whose lung cancer has spread regionally (to regional lymph nodes) is 29.7%, but that survival rate is only 4.7% for patients with distant metastases.
Lumoxiti (Moxetumomab Pasudotox-tdfk) First CD22-Directed Cytotoxin FDA Approved for Relapsed or Refractory Hairy-Cell Leukemia
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.
Lutathera (Lutetium Lu 177 Dotatate) First Radioactive Drug Approved for Gastroenteropancreatic Neuroendocrine Tumors
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.
Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation
Two human genes, BRCA1 and BRCA2 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer.
Tibsovo (Ivosidenib) First Targeted Therapy Approved for Patients with Relapsed or Refractory Acute Myeloid Leukemia and IDH1 Mutation
Acute myeloid leukemia (AML) is a rare but deadly cancer. In 2018, approximately 19,500 new cases of AML were estimated to be diagnosed in the United States and more than 10,600 people to die from the disease. Clinical trials data show that up to 70% of adults with AML have disease that completely responds to initial treatment with cytotoxic chemotherapy. However, the 3-year survival rate for patients with AML remains poor, at approximately 25%.
Udenyca (Pegfilgrastim-cbqv) Second Biosimilar Approved to Reduce the Incidence of Infection Associated with Febrile Neutropenia
Febrile neutropenia is a serious complication of cancer chemotherapy that can require treatment delays and chemotherapy dose reductions, which compromise the efficacy of treatment. Among patients with cancer who are receiving chemotherapy, approximately 1% have febrile neutropenia. This condition affects patient morbidity and mortality and its clinical management requires significant healthcare resources.
Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation
Gene mutations or rearrangements in the tropomyosin receptor kinase (TRK) family of receptor tyrosine kinases are emerging as an important driver of cancer-cell growth in a wide range of cancers. Research has shown that neurotrophic receptor tyrosine kinase (NTRK) genes, which encode for TRK proteins, can fuse abnormally to other genes and enhance cell signals that support tumor growth. NTRK gene fusions are found in a variety of tumor types, including soft-tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.
Vizimpro (Dacomitinib) Approved for First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer with EGFR Mutation
Lung and bronchus cancer is the second most common form of cancer in the United States. In 2018, lung cancer was newly diagnosed in 234,030 individuals, representing 13.5% of all new cancer cases. Lung cancer remains the leading cause of cancer mortality in men and women, accounting for more than 25% of all cancer deaths, which translated to 154,050 deaths in 2018. The relative 5-year survival rate for metastatic lung cancer is only 4.7%.
Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation
Acute myeloid leukemia (AML) is a rare but deadly hematologic cancer. In 2018, approximately 19,500 new cases of AML were diagnosed, and more than 10,600 people died from the disease in the United States. Although up to 70% of adults with AML have a complete response to initial treatment with cytotoxic chemotherapy, the responses are not durable. The 5-year survival rate for people with AML is only 24%.
Prostate cancer is the third most common type of cancer in the United States, after breast cancer and lung cancer. In 2018 alone, 164,690 individuals were diagnosed with prostate cancer, accounting for nearly 10% of all new cancer cases, and 29,430 deaths were attributed to the disease. Prostate cancer is most frequently diagnosed in men aged 65 to 74 years (median age, 66 years). More than 98% of patients with prostate cancer survive ≥5 years; however, the 5-year survival rate drops to 30% for patients with metastatic disease.
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