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Epithelial ovarian cancer is the fifth leading cause of cancer mortality in women and is the leading cause of death due to gynecologic cancer in the United States.

There have been significant improvements in the survival of patients with metastatic colorectal cancer (mCRC) over the past decade. However, patients with the disease who fail to respond to first- or second-line therapies, including chemotherapy and monoclonal antibodies, have few treatment options. Advances in subsequent treatment lines rather than in first- or second-line therapies now drive improvements in survival for these patients.

Ovarian cancer is the most lethal gynecologic cancer and the fifth leading cause of cancer death among women in the United States.1 No effective screening tests are available, and more than 70% of patients are diagnosed with advanced-stage disease.2

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.
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.”
The cancer drugs included in this review were approved for the first time or received additional approvals by the US Food and Drug Administration in 2017 and are grouped here by several categories.

The FDA accelerated the approval of brigatinib (Alunbrig), a new generation of oral ALK inhibitor, for the treatment of patients with ALK-positive metastatic NSCLC who do not tolerate or have had an inadequate response to crizotinib..

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.
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.
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.
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