FDA Approvals, News & Updates

Yonsa (Fine-Particle Abiraterone Acetate) New Formulation Approved for Metastatic Prostate Cancer

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Prostate Cancer

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. [ Read More ]

Xospata (Gilteritinib) First Drug Approved as Monotherapy for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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%. [ Read More ]

Vizimpro (Dacomitinib) Approved for First-Line Treatment of Metastatic Non–Small-Cell Lung Cancer with EGFR Mutation

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lung Cancer

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%. [ Read More ]

Vitrakvi (Larotrectinib) First TRK Inhibitor Approved by the FDA for Solid Tumors Based on a Genetic Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates

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. [ Read More ]

Udenyca (Pegfilgrastim-cbqv) Second Biosimilar Approved to Reduce the Incidence of Infection Associated with Febrile Neutropenia

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates

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. [ Read More ]

Tibsovo (Ivosidenib) First Targeted Therapy Approved for Patients with Relapsed or Refractory Acute Myeloid Leukemia and IDH1 Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

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%. [ Read More ]

Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

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. [ Read More ]

Lutathera (Lutetium Lu 177 Dotatate) First Radioactive Drug Approved for Gastroenteropancreatic Neuroendocrine Tumors

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates

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 ]

Lumoxiti (Moxetumomab Pasudotox-tdfk) First CD22-Directed Cytotoxin FDA Approved for Relapsed or Refractory Hairy-Cell Leukemia

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, 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. [ Read More ]

Lorbrena (Lorlatinib) Approved for the Treatment of Metastatic Non–Small-Cell Lung Cancer with ALK Mutation

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lung Cancer

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. [ Read More ]