FDA Grants Priority Review to Opdivo for Patients With Previously Treated Bladder Cancer

Approval decision slated for March 2017

The FDA has accepted a supplemental biologics license application that seeks to expand the use of nivolumab (Opdivo, Bristol-Myers Squibb) to patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy. The FDA granted the application a priority review, with an action date of March 2, 2017.

The submission was based on data from the phase 2, single-arm CheckMate-275 trial, which evaluated the safety and efficacy of nivolumab in 270 patients with metastatic or unresectable urothelial carcinoma that had progressed or recurred after treatment with a platinum-based agent in the metastatic setting or within one year after neoadjuvant/adjuvant platinum therapy. The study’s primary endpoint was the objective response rate (ORR).

Nivolumab had a confirmed ORR of 19.6% in platinum-refractory patients with metastatic urothelial carcinoma. Responses were observed in both programmed death ligand-1 (PD-L1) expressors and nonexpressors. The confirmed ORRs were 23.8% in patients expressing PD-L1 at greater than or equal to 1% and 16.1% in patients expressing PD-L1 at less than 1%. The confirmed ORRs were 28.4% and 15.8% in patients expressing PD-L1 at greater than or equal to 5% or less than 5%, respectively.

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s immune system to help restore an antitumor immune response.

In July 2014, nivolumab was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Nivolumab is currently approved in more than 57 countries, including the United States.

In the U.S., nivolumab is indicated for the treatment of patients with:

  • BRAF V600 mutation-positive unresectable or metastatic melanoma
  • BRAF V600 wild-type unresectable or metastatic melanoma
  • Unresectable or metastatic melanoma (in combination with ipilimumab [Yervoy, Bristol-Myers Squibb])
  • Metastatic non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
  • Advanced renal cell carcinoma who have received anti-angiogenic therapy
  • Classical Hodgkin’s lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin

Sources: Bristol-Myers Squibb; October 21, 2016; and Bristol-Myers Squibb; October 8, 2016.