Biosimilars and Oral Agents Lead New Approvals in the Cancer Setting

December 18, 2018 by Kathleen Wiley RN, MSN, AOCNS®

A majority of the U.S. Food and Drug Administration (FDA) approvals for cancer agents in the latter part of 2018 represented second and third approvals for new indications in other disease sites. Many were given expedited approval, but with that comes the potential that the incidence of adverse events may be underrepresented because fewer patients received the agents in a clinical trial setting. 

Nurses are critical in sharing the adverse events observed when caring for patients on new agents. Through ONS’s Recognize It; Report It campaign, nurses can understand how to report adverse events to providers for appropriate management and to FDA for widespread dissemination to prescribers and practitioners.

Breast Cancer

Ribociclib in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative metastatic breast cancer

Gastrointestinal Cancers

Ipilimumab for certain metastatic colorectal cancers

Lenvatinib for unresectable hepatocellular carcinoma

Genitourinary Cancer

Enzalutamide for castrate-resistant prostate cancer

Hematologic Cancers

Ivosidenib for relapsed or refractory acute myelogenous leukemia with IDH1 mutation

Mogamulizumab-kpkc for mycosis fungoides or Sezary syndrome

Moxetumomab pasudotox-tdkf for hairy cell leukemia

Duvelisib for relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma

Lung Cancer

Nivolumab for patients with metastatic small cell lung cancer

Melanoma 

Combination encorafenib and binimetinib for BRAF mutation positive unresectable or metastatic melanoma


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