The end of 2016 proved to be a busy and exciting time for cancer breakthroughs, seeing eight new U.S. Food and Drug Administration (FDA) approvals for immunotherapy and biotherapy. Following is a summary of cancer-related FDA approvals in the last quarter of 2016, indications for treatment, and associated clinical implications.
Nivolumab for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer (NSCLC)
- The dosing for three implications changed to 240 mg IV every two weeks.
- Approval for the change was based on pharmacokinetic testing.
- Dosing remains 3 mg/kg via IV every two weeks for other indications.
Erlotinib for NLCLC with specific tumor mutations
Modified approval was given to only patients with a specific epidermal growth factor receptor (EGFR).
Atezolizumab for metastatic NSCLC with progression after platinum-based chemotherapy
- This PDL-1 inhibitor (checkpoint inhibitor) is administered as 1,200 mg via IV every three weeks.
- Fatigue and other immune-related adverse events are most commonly seen.
Olaratumab for soft tissue sarcoma
- An open-label trial randomized patients to chemotherapy alone or olaratumab + chemotherapy. The olaratumab + chemotherapy arm had higher overall survival.
- Dosing is 15 mg/kg on days 1 and 8 of a 21-day cycle.
Pembrolizumab for metastatic NSCLC with PD-L1 expression
- This is the first FDA approval of a checkpoint inhibitor as first-line treatment.
- Dosing is 200 mg via IV every three weeks.
- Common side effects include fatigue and immune-related adverse events (especially pneumonitis).
Nivolumab for metastatic head and neck squamous cell carcinoma with progression on or after platinum-based therapy
- Approval was based on a trial in which patients were randomized to either nivolumab or one of three chemotherapy drugs (investigator’s choice). The nivolumab arm showed improved overall survival versus all three chemotherapy arms.
- The dosing is 3 mg/kg via IV every two weeks.
Daratumumab for multiple myeloma after one prior therapy
- Increased overall survival when added to popular myeloma regimens.
- The dosing is 16 mg/kg.
- Common side effects include infusion reactions, diarrhea, nausea, and fatigue.
Rucaparib for advanced ovarian cancer with BRCA mutation
- The dosing is 600 mg given orally, twice a day.
- Common side effects include nausea, fatigue, anemia, and abdominal pain.
Many of the approvals involved agents that had already been approved for antineoplastic use, but clinical data indicated that modifications are necessary to allow for the most therapeutic responses. Many approved agents see different doses and schedules based on clinical indication, emphasizing the need for oncology nurses to independently verify orders match recommended dosing based on indication and treatment regimen. The nomenclature and mechanism of action of these immunotherapy and biotherapy agents offer nurses vital insight into expected adverse events.