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Following the advent of molecularly targeted agents, and more recently, immunotherapy, over the past few decades, we have witnessed dramatic changes in the treatment paradigms for many types of cancer. These advancements were driven by molecular profiling that enabled the identification of those patient populations most likely to benefit from targeted therapy and/or immunotherapy—that is, precision medicine.
There is renewed interest in MSI analysis because the MSI-H/dMMR phenotype has emerged as an actionable predictive biomarker for immune checkpoint blockade therapy in different cancer types. This review presents available evidence supporting the clinical relevance and predictive value of MSI/dMMR in cancers, including those treated with immune checkpoint inhibitors (ICIs), and outlines the diagnostic approaches developed to assess MSI/dMMR in clinical practice.

PD-L1 expression is a rational biomarker to predict response to PD-1/PD-L1 ICI therapy, and has been studied extensively in clinical trials. A recurring theme emerging from available clinical data is that high levels of tumor cell membrane PD-L1 expression correlate with better outcomes with PD-1/PD-L1 blockade.

More recently, immunologic therapy has emerged as an important treatment option for many types of cancers, based on demonstrations of unprecedented efficacy. This radical shift in treatment has come with the recognition of the essential role of the immune system in the surveillance and eradication of neoplastic cells, particularly modulation of the immune checkpoint protein cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) and the programmed death-1 (PD-1) receptor and its ligand, PD-L1.

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.
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