July 25, 2017
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FDA accepts application to update Opdivo monotherapy dosing

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The FDA accepted a supplemental biologics license application that seeks to update nivolumab dosing, according to the drug’s manufacturer.

The updated dose of nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 immune checkpoint inhibitor, would include 480 mg nivolumab infused over 30 minutes every 4 weeks for all approved monotherapy indications.

“Filing for 4-week dosing infused over 30 minutes across approved Opdivo monotherapy indications supports our commitment to address cancer care from all angles,” Murdo Gordon, executive vice president and chief commercial officer at Bristol-Myers Squibb, said in a company-issued press release. “Driving innovation and making treatment more convenient for health care providers, caregivers and patients living with this disease is a priority for Bristol-Myers Squibb.”

Nivolumab is approved for the following indications:

  • monotherapy for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma;
  • monotherapy for patients with BRAF V600 wild-type unresectable or metastatic melanoma;
  • in combination with ipilimumab (Yervoy Bristol-Myers Squibb) for patients with unresectable or metastatic melanoma;
  • metastatic non-small cell lung cancer that progressed on or after platinum-based chemotherapy;
  • treatment of patients with advanced renal cell carcinoma who received prior anti-angiogenic therapy;
  • treatment of adults with classical Hodgkin lymphoma that relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and brentuximab vedotin (Adcetris, Seattle Genetics), or after three or more lines of systemic therapy, including auto-HSCT;
  • recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-based therapy; and
  • patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA set an action date of March 5, 2018.