Latest FDA Cancer Treatment Approvals Trend Toward New Indications

June 28, 2018 by Kathleen Wiley RN, MSN, AOCNS®

What is unique about the most recent U.S. Food and Drug Administration (FDA) approvals in the oncology/hematology area is that almost all are for new indications of existing agents as opposed to new agents. This is not surprising because many of the agents target specific bioassays or tumor markers instead of a specific disease site. Oncology nurses need to be aware of the changes because treatments that they have become accustomed to giving for one indication may soon be given for others as well.

Dosing Updates

Nivolumab, a PD-1 inhibitor, already approved for a variety of oncologic conditions, received approval for updated dosing recommendations:

Breast Cancer

Abemaciclib for hormone receptor-positive, HER2-negative metastatic breast cancer:

Lung Cancer

Durvalumab after chemotherapy in stage III non-small cell lung cancer:

Genitourinary Cancers

Abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer:

Apalutamide for nonmetastatic castration-resistant prostate cancer:

Hematologic Malignancies

Brentuximab vedotin for classical Hodgkin lymphoma:

Nilotinib for Philadelphia chromosome-positive chronic myeloid leukemia:

As noted in each FDA approval alert, reporting adverse events to MedWatch helps give the FDA a better sense of the agents’ acute and long-term effects and fully understand the survivorship needs of patients on these agents. Oncology nurses should begin by reporting adverse events to providers for appropriate management, then discuss as a team whether it’s necessary to report them to the FDA for more widespread dissemination (see sidebar).

Visit ONS Voice’s FDA Articles for the most up-to-date list of FDA oncology drug approvals.

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