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.
Nivolumab, a PD-1 inhibitor, already approved for a variety of oncologic conditions, received approval for updated dosing recommendations:
- Dosing can now be either 240 mg every two weeks or 480 mg every four weeks.
- Administration remains via IV, but it can be infused over 30 minutes.
Abemaciclib for hormone receptor-positive, HER2-negative metastatic breast cancer:
- Approved for postmenopausal women.
- Treatment must be in combination with an aromatase inhibitor.
- Recommended dosing is 150 mg orally twice daily with or without food.
- Common adverse events include diarrhea, neutropenia, fatigue, and infection.
Durvalumab after chemotherapy in stage III non-small cell lung cancer:
- Approval is based on patients in clinical trials who started durvalumab within 42 days of a platinum-based chemotherapy regimen and radiation and demonstrated longer progression-free survival than those who were treated with chemotherapy and radiation alone.
- Recommended dosing for this indication is 10 mg/kg via IV every two weeks.
- Common adverse events include fatigue, cough, pneumonitis, and immune-related adverse events.
Abiraterone acetate plus prednisone for metastatic castration-sensitive prostate cancer:
- Initially approved in 2011 for castration-resistant prostate cancer.
- Recommended dosing is 1,000 mg orally with 5 mg oral prednisone once daily.
- Common adverse events include hypertension, hot flashes, and hypokalemia.
- Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
Apalutamide for nonmetastatic castration-resistant prostate cancer:
- Approval is based on improved metastasis-free survival in treatment cohort (apalutamide plus medical or surgical castration) as opposed to medical or surgical castration plus placebo.
- Common adverse events include fatigue, hypertension, rash, and diarrhea.
- Recommended dosing is 240 mg once daily. Pills are currently available in 60 mg tablets
Brentuximab vedotin for classical Hodgkin lymphoma:
- Recommended dosing for this indication is 1.2 mg/kg (not to exceed 120 mg) via IV every two weeks for 12 doses.
- Common adverse events include anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue, and neutropenia. Peripheral neuropathy was dose limiting in some instances.
Nilotinib for Philadelphia chromosome-positive chronic myeloid leukemia:
- Approved for pediatric patients older than 1 year.
- Patients must have failed or been intolerant to prior tyrosine kinase inhibitor therapy.
- Dosing recommendations is 230 mg/m2 orally twice a day (rounded to the nearest 50 mg).
- Common adverse events include hyperbilirubinemia, thrombocytopenia, rash, and neutropenia. Grade 3 or 4 events were hyperbilirubinemia and elevated alanine aminotransferase.
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.