The sBLA proposed to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma that has progressed on or after platinum-containing therapy.
The sBLA submission was based on evidence from the CheckMate -275, a Phase 2, single-arm clinical study (n=270) evaluating the safety and efficacy of Opdivo in patients with metastatic or unresectable urothelial carcinoma that has progressed or recurred after treatment with a platinum-based agent in the metastatic setting or within 1 year after neoadjuvant/adjuvant platinum therapy.
The primary endpoint was confirmed objective response rate (ORR) based on assessments by the blinded independent review committee. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life.
Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor works by using the body’s own immune system to help restore anti-tumor immune response. It is currently approved to treat advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy, classical Hodgkin lymphoma that relapsed or progressed after autologous HSCT and post-transplantation brentuximab vedotin, BRAF V600 wild-type or BRAF V600 mutation (+) unresectable or metastatic melanoma, in combination with ipilimumab for unresectable or metastatic melanoma, and metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
The FDA had previously granted the application Priority Review and Breakthrough Therapy Designation in June 2016. The FDA action date is set for March 2, 2017.
For more information call (855) 673-4861 or visit Opdivo.com.