Nurses Play Critical Role in New Dosing Regimen for Nivolumab

While the new FDA approval of 4-week dosing adds more flexibility in scheduling, it reduces the number of times patients would be monitored in person for adverse effects (AEs), so nurses need to be alert to and educated about potential AEs.

Following a recent FDA approval, nivolumab (Opdivo) may now be administered at different two doses, every 2 or 4 weeks. While this allows for a more flexible treatment schedule among health care providers and patients, it also increases the need for nurses to be educated on the potential adverse effects associated with anti-PD-1 therapies.

“From my practice days, the nursing staff at any oncology office or emergency room are the most critical people in that office because they have very close relationships with the patients,” Awny Farajallah, MD, Vice President, Head of US Medical at Bristol-Myers Squibb (BMS)—nivolumab’s manufacturer–said in an interview with Oncology Nursing News.

“They are able to identify things and flag them to the physician very early on,” he added. “So, this label, while it offers health care providers and patients flexibility, the nurses play a role in informing the patients of the option, and also informing on what they are looking for from an adverse event management standpoint.”

In its decision, the FDA approved a supplemental biologics license application to add a 4-week dosing schedule of 480 mg of nivolumab across several of the PD-1 inhibitor’s indications—the agent is also approved for a 2-week dosing schedule of 240 mg. In addition, the new regimen would decrease infusion time in half, from 60 minutes to 30.

The 4-week dosing schedule is approved for the following indications:

  • metastatic melanoma (monotherapy or monotherapy phase after combination treatment with Yervoy [ipilimumab]);
  • previously treated metastatic non—small cell lung cancer (NSCLC);
  • advanced renal cell carcinoma (RCC) following prior anti-angiogenic therapy;
  • previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy;
  • classical Hodgkin lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT;
  • recurrent/metastatic squamous cell carcinoma of the head and neck following platinum-based therapy;
  • hepatocellular carcinoma after prior sorafenib therapy; and
  • adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

Therefore, it is important for every member of the health care team to educate themselves on potential adverse effects, given some patients will not be seeing their physicians as frequently.

“Oncology care teams will need to be educated when to have patients return to clinic for further evaluation of their symptoms in order to diagnose and treat side effects in a timely fashion,” said Julie Brahmer, MD, chair of the expert panel that developed the recently issued American Society of Clinical Oncology (ASCO) guidelines on understanding and managing immunotherapy-related toxicities.

To help with this initiative, BMS has a variety of efforts that may help.

“As a matter of fact, we make a concerted effort to work with our nursing oncology community and support them in this critical role as they are delivering these treatments to patients,” said Farajallah. “For instance, we are working on educational summits that were created with the Oncology Nursing Society, offering a peer-to-peer forum to support nurses on identifying symptoms, how to make treatment decisions with the patient, and really looking at all of the different scenarios with BMS Immuno-Oncology medications.”