FDA Approvals, News & Updates

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 ]

Imfinzi First Treatment Approved to Reduce Disease Progression in Unresectable Stage III NSCLC After Chemoradiation

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates

On February 16, 2018, the FDA approved an expanded indication for durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of patients with unresectable stage III non–small-cell lung cancer (NSCLC) that did not progress after chemoradiation. Durvalumab received accelerated approval in 2017 for the treatment of certain patients with metastatic or locally advanced bladder cancer. [ Read More ]

Erleada First Therapy Approved for Patients with Nonmetastatic Castration-Resistant Prostate Cancer

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates

On February 14, 2018, apalu­tamide (Erleada; Janssen Pharmaceuticals), an androgen receptor inhibitor, received accelerated approval by the FDA for the treatment of patients with nonmetastatic, cas­tration-resistant prostate cancer (CRPC). Apalutamide is the first treatment approved by the FDA for patients with nonmetastatic CRPC, and was approved under the FDA priority review process. [ Read More ]

Zytiga Receives New Indication, with Prednisone, for Metastatic, High-Risk Castration-Sensitive Prostate Cancer

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates, Prostate Cancer

On February 7, 2018, abiraterone acetate (Zytiga; Janssen Biotech) received FDA approval for use, in combination with prednisone, for the treatment of patients with metastatic, high-risk castration-sensitive prostate cancer (CSPC). The FDA approved this new indication under its priority review program. [ Read More ]

Lutathera First Radioactive Drug Approved for Adults with Gastroentero­pancreatic Neuroendocrine Tumors

March 2018, Vol 8, No 3 - FDA Approvals, News & Updates

On January 26, 2018, the FDA approved lutetium Lu 177 dotatate (Lutathera; Advanced Accelerator Applications), a radioactive drug, for the treatment of adults with somato­statin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutetium Lu 177 dotatate was approved under the FDA’s priority review process, and was designated as an orphan drug. [ Read More ]