Novel Infusion Options Approved for Opdivo

Bristol-Myers Squibb (BMS) recently announced the FDA has approved its supplemental Biologics License Application (sBLA) to update the nivolumab (Opdivo) dosing schedule, according to a press release.
 
The label update includes a dosing option of nivolumab 480-mg infused every 4 weeks (Q4W) for nearly all indications.
 
The new dosing options will provide health care providers with the flexibility to individualize patient care, according to BMS.
 
“At Bristol-Myers Squibb, we are united in our mission to fight cancer from all angles and recognize every patient has unique needs. From the introduction of our first Immuno-Oncology agent through today’s approval of flexible dosing options at 2- or 4-week intervals, we are relentless in pursuing innovative options for the cancer community,” Johanna Mercier, head, US Commercial, BMS said in a press release. “With this approval, we now offer the most robust range of dosing options for an immuno-oncology medicine, providing enhanced flexibility to help address each patient’s specific needs.”
 
Previously, nivolumab was available as a 240-mg infusion administered every 2 weeks. Now, patients can receive the Q4W flat dose if necessary.   
 
The Q4W flat dose option is approved for:
 
  • metastatic melanoma
  • previously-treated non-small cell lung cancer
  • advanced renal cell carcinoma
  • previously-treated urothelial carcinoma
  • classical non-Hodgkin lymphoma
  • hepatocellular carcinoma
  • resected melanoma with lymph node involvement or metastatic progression
 
Additionally, the FDA approved a shorter administration time of nivolumab as a 30-minute infusion option across all indications, according to the release.
 
“We continuously learn new ways to individualize treatment with Immuno-Oncology therapies, and in my experience, what works for one patient may not be optimal for another,” Jeffrey S. Weber, MD, PhD, deputy director of the Perlmutter Cancer Center at NYU Langone Health, said in a press release. “For instance, some patients may need the support of 2-week visits with their health care team, while for others, a 4-week interval may be more appropriate and better suited to their treatment needs. With this approval, we now have additional ways to help tailor patient care.”




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