Biosimilars and Oral Agents Lead New Approvals in the Cancer Setting
A majority of the U.S. Food and Drug Administration (FDA) approvals for cancer agents in the latter part of 2018 represented second and third approvals for new indications in other disease sites. Many were given expedited approval, but with that comes the potential that the incidence of adverse events may be underrepresented because fewer patients received the agents in a clinical trial setting.
Nurses are critical in sharing the adverse events observed when caring for patients on new agents. Through ONS’s Recognize It; Report It campaign (https://voice.ons.org/news-and-views/ons-creates-campaign-to-encourage-adverse-event-reporting), nurses can understand how to report adverse events to providers for appropriate management and to FDA for widespread dissemination to prescribers and practitioners.
Ribociclib in combination with an aromatase inhibitor (https://voice.ons.org/news-and-views/fda-expands-ribociclib-indication-in-hr-positive-her2-negative-advanced-metastatic) for pre/perimenopausal women with HR-positive, HER2-negative metastatic breast cancer
- The previously approved indication was for postmenopausal women only.
- Common adverse events include neutropenia, nausea, infection, fatigue, diarrhea, and vomiting.
- Recommended dosing is 600 mg orally once daily for the first 21 days of a 28-day cycle.
- The new indication adds ipilimumab, a CTLA-4 inhibitor, to nivolumab for microsatellite instability high or mismatch repair-deficient metastatic colorectal cancer.
- The most common adverse events for combination ipilimumab and nivolumab include fatigue, diarrhea, pyrexia, musculoskeletal pain, abdominal, pain, and pruritis.
- Patients should have been previously treated with a chemotherapy regimen.
- Approved for previously untreated metastatic or unresectable disease.
- Common adverse events include hypertension, fatigue, diarrhea, decreased appetite, arthralgias, and abdominal pain.
- Recommended dosing is 12 mg orally in patients 60 kg or more or 8 mg orally once daily in patients less than 60 kg.
- The previous indication was for metastatic disease only.
- Common adverse events include fatigue, hot flush, hypertension, dizziness, nausea, and falls.
- Recommended dosing is 160 mg orally once daily.
- Common adverse events include fatigue, leukocytosis, arthralgia, diarrhea, and dyspnea.
- Studies showed improvement in transfusion dependency among treated patients.
- Recommended dosing is 500 mg orally once daily.
- This is a new biosimilar approval in this setting.
- Adverse events mirror those of mogamulizumab and include rash, infusion-related reaction, fatigue, diarrhea, musculoskeletal pain, and upper-respiratory infection.
- Recommended dosing also mirrors mogamulizumab and is 1 mg/kg via IV over at least one hour.
- This is a biosimilar for a CD22-directed monoclonal antibody.
- Common adverse events include infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, and constipation.
- Recommended dosing is 0.04 mg/kg administered as a 30-minute IV infusion on days 1, 3, and 5 of each 28-day cycle for a maximum of six cycles.
Duvelisib for relapsed/refractory chronic lymphocytic leukemia (https://voice.ons.org/news-and-views/fda-approves-duvelisib-for-adult-patients-with-relapsed-or-refractory-cll-or-sll) or small lymphocytic lymphoma
- Patients should have completed at least two prior therapies.
- Serious or fatal adverse events include infection, diarrhea or colitis, and pneumonia. Other adverse events include rash, fatigue, pyrexia, and cough.
- Recommended dosing is 25 mg orally twice a day.
Nivolumab for patients (https://voice.ons.org/news-and-views/fda-grants-nivolumab-accelerated-approval-for-third-line-treatment-of-metastatic) with metastatic small cell lung cancer
- Approval was extended to patients with metastatic small cell lung cancer, regardless of PD-L1 status.
- Patients need to have had at least one other line of platinum-based chemotherapy.
- Common adverse events are those of nivolumab for other approved indications: fatigue, decreased appetite, musculoskeletal pain, dyspnea, nausea, diarrhea, and cough.
- Recommended dosing is 240 mg every two weeks over 30 minutes.
Combination encorafenib and binimetinib (https://voice.ons.org/news-and-views/fda-approves-encorafenib-and-binimetinib-in-combination-for-unresectable-or) for BRAF mutation positive unresectable or metastatic melanoma
- The recommended dosing is encorafenib 450 mg orally once daily and binimetinib 45 mg orally twice daily.
- Common adverse events include fatigue, nausea, diarrhea, vomiting, abdominal pain, and arthralgia.