Biosimilars and Oral Agents Lead New Approvals in the Cancer Setting

December 18, 2018 by Kathleen Wiley MSN, RN, 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


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

Copyright © 2018 by the Oncology Nursing Society. User has permission to print one copy for personal or unit-based educational use. Contact for quantity reprints.