FDA Approvals, News & Updates

Zejula (Niraparib) First PARP Inhibitor Approved for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Ovarian Cancer

In ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer, malignant cells form in the tissue covering the ovary or lining the fallopian tube or peritoneum. According to the American Cancer Society, in 2017 more than 22,000 women in the United States were estimated to be diagnosed with these cancers and more than 14,000 to die from them. [ Read More ]

Yescarta (Axicabtagene Ciloleucel) Second CAR T-Cell Therapy Approved for Patients with Certain Types of Large B-Cell Lymphoma

Loretta Fala

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lymphoma

Diffuse large B-cell lymphoma (DLBCL), a form of cancer that starts in the lymphatic system, is the most common type of non-Hodgkin lymphoma (NHL) in adults. In the United States, approximately 72,000 new cases of NHL are diagnosed annually; more than 20,000 people were estimated to die from the disease in 2017. [ Read More ]

Vyxeos (Daunorubicin and Cytarabine) Liposomal Combination First Treatment Approved for Patients with High-Risk Acute Myeloid Leukemia

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

Acute myeloid leukemia (AML) is a rare but deadly cancer. Approximately 21,400 new cases of AML were diagnosed in 2017 in the United States, and nearly 10,600 people died from the disease. Approximately 60% to 70% of adults with AML respond to initial treatment with cytotoxic chemotherapy. However, the 5-year survival rate for patients with AML remains poor at approximately 27%. [ Read More ]

Verzenio (Abemaciclib) a New CDK4/CDK6 Inhibitor Approved for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Loretta Fala

2018 Third Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

Breast cancer affects more women than any other type of cancer, and represents 15% of all new cancer cases in the United States. A total of 252,710 new breast cancer cases were estimated to be diagnosed in 2017, and more than 40,600 deaths. The prognosis worsens for patients with locally advanced breast cancer and even more so for those with metastatic disease. [ Read More ]

Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - Bladder Cancer, FDA Approvals, News & Updates

Urothelial carcinoma is the most common subtype of bladder cancer, accounting for more than 90% of bladder cancer diagnoses in the United States. In 2017, more than 79,000 bladder cancer cases were diagnosed in the United States, and more than 16,000 people died from this disease. The prognosis is favorable for patients with localized disease, with a 5-year relative survival rate of 78% for all stages of bladder cancer, which decreases to 5% for patients with distant disease. [ Read More ]

Revlimid (Lenalidomide) First Drug Approved for Post-Transplant Maintenance Therapy in Multiple Myeloma

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Multiple Myeloma

Multiple myeloma is a cancer of plasma cells in the bone marrow that often leads to bone destruction and bone marrow failure. According to the American Cancer Society, more than 30,280 new cases of multiple myeloma will be diagnosed in 2017, and 12,590 deaths will be attributed to the disease. In the past 20 years, mortality rates associated with multiple myeloma have declined. Novel therapies, as well as improvements in autologous hematopoietic stem-cell transplantation (HSCT) procedures and supportive care, have contributed to extended survival for patients with this malignancy. [ Read More ]

Kymriah (Tisagenlecleucel) for Young Patients with Acute Lymphoblastic Leukemia: First FDA-Approved Gene Therapy

Loretta Fala

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that affects the white blood cells (lymphocytes). In 2017, 5970 new patients were estimated to be diagnosed with ALL and 1440 individuals to die from this disease. ALL is diagnosed most often in children, adolescents, and young adults, with a median age of 15 years at diagnosis. [ Read More ]

Kisqali (Ribociclib): Second CDK4/CDK6 Inhibitor Approved for Postmenopausal Women with HR-Positive, HER2-Negative Advanced Breast Cancer

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

Breast cancer is one of the most common cancer diagnoses in the United States. The National Cancer Institute estimates that 252,710 American women will be diagnosed with breast cancer and 40,610 will die from the disease in 2017. For the majority (62%) of women with breast cancer, the disease is confined to the breast, and the 5-year survival approaches 100%. However, for women with metastatic disease, the likelihood of survival at 5 years drops to 27%. [ Read More ]

Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - Bladder Cancer, FDA Approvals, News & Updates

Urothelial carcinoma is the primary subtype of bladder cancer, which is the sixth most common cancer in the United States. More than 79,000 cases of bladder cancer were estimated to be diagnosed, and nearly 17,000 people to die from this disease in 2017. [ Read More ]

Imbruvica (Ibrutinib) First Drug Approved Specifically for Marginal-Zone Lymphoma and for Chronic Graft-versus-Host Disease

Lisa A. Raedler, PhD, RPh

2018 Third Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lymphoma

Marginal-zone lymphoma (MZL) arises from B-lymphocytes in the marginal zone of lymphoid tissue. This slow-growing indolent B-cell lymphoma represents approximately 12% of all cases of non-Hodgkin lymphoma (NHL) in adults. MZL is divided into 3 subtypes, including mucosa-associated lymphoid tissue (MALT), nodal MZL, and splenic MZL. MALT lymphoma is the most common of these subtypes and occurs in the stomach, intestines, salivary glands, thyroid, eyes, and lungs. In MALT lymphoma, autoimmune processes or chronic infection cause B-cells to accumulate. Helicobacter pylori is 1 of at least 6 microbial species associated with lymphoproliferation in gastric MALT lymphoma. [ Read More ]