FDA’s Latest Approved Drugs and Indications Include Two Oral Agents

June 25, 2019 by Kathleen Wiley MSN, RN, AOCNS®

Because two oral therapies received new indications in the U.S. Food and Drug Administration’s (FDA’s) most recent round of approvals, oncology nurses will want to focus on ways to manage patients in the home.

Assessing oral adherence, encouraging patients to report adverse events, and ensuring their understanding of complex dosing regimens are critical components of nursing care. ONS offers an oral adherence toolkit (https://www.ons.org/toolkits/oral-adherence-toolkit) and oral chemotherapy patient education sheets (https://www.ons.org/toolkits/oral-chemotherapy-education-sheets) to help with patient management. 

Following is a summary of FDA approvals for new agents and indications in the cancer setting for the first part of 2019. As always, refer to the package insert for the most up-to-date dosing recommendations and administration considerations. 

Breast Cancer

Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) for HER2-positive breast cancer (https://voice.ons.org/news-and-views/fda-approves-trastuzumab-and-hyaluronidase-oysk-injection-for-subcutaneous-use)

Atezolizumab (Tecentriq®) for PD-L1 positive locally advanced (https://voice.ons.org/news-and-views/fda-approves-atezolizumab-for-extensive-stage-small-cell-lung-cancer) or metastatic triple-negative breast cancer

Gastrointestinal Cancers

Trifluridine and tipiracil (Lonsurf®) for recurrent metastatic gastric or gastroesophageal junction adenocarcinoma (https://voice.ons.org/news-and-views/fda-approves-trifluridine-and-tipiracil-tablet)

Hepatocellular Carcinoma 

Cabozantinib (Carometyx®) for patients with hepatocellular carcinoma previously treated with sorafenib (https://voice.ons.org/news-and-views/fda-approves-cabozantinib-for-hepatocellular-carcinoma)

Lung Cancer 

Atezolizumab in combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (https://voice.ons.org/news-and-views/fda-approves-atezolizumab-for-extensive-stage-small-cell-lung-cancer)


Pembrolizumab (Keytruda®) for adjuvant therapy (https://voice.ons.org/news-and-views/fda-approves-pembrolizumab-for-adjuvant-treatment-of-melanoma)

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