Biosimilars, Oral Agents, and Drugs Targeting Genetic Mutations Are Creating a Paradigm Shift in Cancer Treatment

March 19, 2019 by Kathleen Wiley MSN, RN, AOCNS®

New treatment options continue to emerge for diseases that until recently had limited, if any, treatment choice. Nurses are seeing more changes in the way treatment regimens come together, biosimilars are presenting viable options for patients, and genetic mutations, as opposed to disease sites, are at the forefront of drug development.  

Many of the newly U.S. Food and Drug Administration (FDA)-approved agents received expedited approval, meaning far fewer patients were observed under a rigorous clinical trial environment; therefore, it’s more critical than ever that nurses share the adverse events they identify for patients on these 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. Learn more at ons.org/toolkits/recognize-it-report-it.  

Identified Genetic Mutations

Cancer care is in a fundamental shift from disease-focused drugs to tumor marker or genetic mutation focused. One example is larotrectinib, which is approved for any solid organ malignancy (https://voice.ons.org/news-and-views/fda-approves-larotrectinib-for-solid-tumors-with-ntrk-gene-fusions) that expresses a neurotrophic receptor tyrosine kinase (NTRK) gene fusion, rather than a specific diseases site.

Hematologic Malignancies

Hepatocellular Carcinoma

Lung Cancer

Cancer Prevention

In December 2018, FDA expanded approval (https://voice.ons.org/news-and-views/hpv-9-valent-vaccine-approved-for-people-aged-27-45) of the human papillomavirus (HPV) 9-valent vaccine to people aged 27–45. The vaccine is about 88% effective in preventing HPV infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to the nine HPV types. Oncology nurses are paramount in educating patients about options for primary prevention of first or subsequent cancers.


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