Patients Now Have the Option to Undergo Immunotherapy Less Frequently

The Food and Drug Administration (FDA) has approved a supplemental biologics license application adding a four-week dosing schedule for Opdivo (nivolumab) across several of the PD-1 inhibitor’s indications.

Physicians can now prescribe the new dosing schedule of 480 mg of Opdivo infused every 30 minutes every four weeks for these approved 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 following prior antiangiogenic 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 Adcetris (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 Nexavar (sorafenib) therapy

• Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease.

Patients can now receive either the new four-week dosing schedule, or the previously approved schedule of 240 mg every two weeks, now available in a new 240 mg vial, according to Bristol-Myers Squibb, the manufacturer of Opdivo.

“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, M.D., Ph.D., 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 health care 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 Webber.

The FDA first approved Opdivo as a single agent for advanced melanoma in December 2014, as a treatment for patients with unresectable or metastatic melanoma and disease progression following Yervoy 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.