The FDA has approved a supplemental biologics license application adding a 4-week dosing schedule for nivolumab (Opdivo) across several of the PD-1 inhibitor’s indications.
Physicians can now prescribe the new dosing schedule of 480 mg of nivolumab infused every 30 minutes every 4 weeks for approved indications, including previously treated metastatic non–small cell lung cancer (NSCLC).
Physicians now have the option of using either the new 4-week dosing schedule or the previously approved schedule of 240 mg every 2 weeks, now available in a new 240 mg vial, according to Bristol-Myers Squibb, the manufacturer of nivolumab.
“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 and professor of medicine at NYU School of Medicine, said in a statement.
“For instance, some patients may need the support of two-week visits with their healthcare team, while for others, a four-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,” added Weber.
Research presented at the 2017 AACR Annual Meeting indicated that safety and efficacy would be similar between a nivolumab dosing schedule of 480 mg every 4 weeks compared with 3 mg/kg every 2 weeks. Using quantitative clinical pharmacology analyses and safety assessments, the investigators examined the predicted risk/benefit profile of the less frequent 480-mg regimen relative to the 3-mg/kg regimen.
The FDA first approved nivolumab as a single agent for advanced melanoma in December 2014, as a treatment for patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600–positive, a BRAF inhibitor.
“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 two- or four-week intervals, we are relentless in pursuing innovative options for the cancer community,” Johanna Mercier, head, US Commercial, Bristol-Myers Squibb, 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,” added Mercier.