FDA Approvals, News & Updates

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 - FDA Approvals, News & Updates, Urothelial Cancer

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 ]

Calquence (Acalabrutinib) Approved for Relapsed or Refractory Mantle-Cell Lymphoma in Adults

Lisa A. Raedler, PhD, RPh

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

Mantle-cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma (NHL), comprising approximately ≥4% of NHL cases in the United States. Mantle-cell lymphoma most often affects men aged ≥60 years, and the key factors affecting prognosis include the patient’s age, performance status, lactate dehydrogenase levels, and white blood cell count. [ Read More ]

Alunbrig (Brigatinib) Approved for Metastatic NSCLC with ALK Mutation

Lisa A. Raedler, PhD, RPh

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

Lung cancer is one of the most common cancers in men and women, and is the leading cause of cancer-related mortality in the United States. According to the American Cancer Society, more than 155,000 Americans will die from lung cancer in 2017, representing approximately 25% of all cancer deaths. Non–small-cell lung cancer (NSCLC), the most common form of the disease, accounts for 80% to 85% of all lung cancer cases. [ Read More ]

FDA Approvals in 2017 Represent a 21-Year High

Gary M. Owens, MD

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

In 2017, the US Food and Drug Administration (FDA) approved 46 new drugs, a 21-year high. In addition to these impressive approvals, the first-ever 3 gene therapies were also approved. FDA Commissioner Scott Gottlieb, MD, noted that these approvals represent “a whole new scientific paradigm for the treatment of serious diseases.” [ Read More ]

Welcome to the Third Annual Oncology Guide to New FDA Approvals

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

The Lynx Group is pleased to bring you the Third 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 hematology oncology drugs approved by the US Food and Drug Administration (FDA) in 2017. This practical tool offers a quick, yet detailed, evidence-based resource for oncology providers to guide their management of patients with cancer. [ Read More ]