Latest FDA Cancer Treatment Approvals Trend Toward New Indications

June 28, 2018 by Kathleen Wiley MSN, RN, 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:

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.

Breast Cancer

Abemaciclib (https://voice.ons.org/news-and-views/fda-approves-abemaciclib-as-initial-therapy-for-hr-positive-her2-negative-metastatic) 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.

Recognize It; Report It

As frontline care providers and the most frequent points of contact for patients and families, oncology nurses are in a key position to identify adverse events patients may be experiencing with new drug approvals. You have a responsibility to recognize them and report them.

Recognize adverse events that patients on investigational or newly approved agents that received fast track approval may be experiencing. The Common Terminology Criteria for Adverse Events (ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm) will help you assess and grade symptoms.
Report any observed adverse events:

Document them in the patient’s health records.
Report them directly to the patient’s provider or interprofessional team.
Through a team discussion, determine whether the report should be shared at a more global level, either institution-wide or nationally through the FDA MedWatch system.
Although not every adverse event warrants a MedWatch report, if the team decides one is needed, submit the report through www.fda.gov/Safety/MedWatch/default.htm (http://www.fda.gov/Safety/MedWatch/default.htm).

Lung Cancer

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.

Genitourinary Cancers

Abiraterone (https://voice.ons.org/news-and-views/fda-approves-abiraterone-acetate-with-prednisone-for-high-risk-metastatic-cspc) 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 (https://voice.ons.org/news-and-views/fda-approves-apalutamide-for-nonmetastatic-castration-resistant-prostate-cancer) 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

Hematologic Malignancies

Brentuximab (https://voice.ons.org/news-and-views/fda-approves-brentuximab-vedotin-for-previously-untreated-stage-iii-iv-classical) 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 (https://voice.ons.org/topic/us-food-and-drug-administration-fda) for the most up-to-date list of FDA oncology drug approvals.

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