The European Medicines Agency (EMA) has validated the type II variation application submitted by Bristol-Myers Squibb, requesting that Opdivo (nivolumab) — an approved treatment for melanoma and select other cancers — also be approved to treat advanced forms of bladder cancer. Specifically, the company is seeking to extend Opdivo’s indications to include adults with locally advanced unresectable or metastatic urothelial carcinoma (mUC) who failed prior platinum-based chemotherapy.
By validating the application, EMA confirms the submission is complete and the review process may begin.
“The high frequency of metastatic urothelial carcinoma and its relapsing nature highlight the substantial need for new treatment approaches with high and durable responses,” Fouad Namouni, MD, head of development, Oncology, Bristol-Myers Squibb, said in a press release. “We look forward to working with the EMA to potentially extend the use of Opdivo and bring the science of Immuno-Oncology to help patients in Europe fight this difficult-to-treat, advanced form of bladder cancer.”
Opdivo is a monoclonal antibody that targets the checkpoint receptor PD-1 expressed on activated T-cells, blocking its interaction with the PD-L1 found at the surface of cancer cells. PD-1/PD-L1 interaction impairs the T-cells from recognizing and attacking malignant cells, and inhibiting this pathway has been shown to improve an anti-tumor immune response.
Opdivo became the first PD-1 inhibitor to receive regulatory approval in July 2014, and is currently approved in 54 countries, including those of the E.U., and in the U.S.
In the U.S., Opdivo is approved for the following indications:
- as monotherapy for patients with unresectable or metastatic melanoma without the BRAF 600 mutation;
- as monotherapy for patients with BRAF V600-positive unresectable or metastatic melanoma;
- in combination with Yervoy (ipilimimab) for patients with unresectable or metastatic melanoma;
- in patients with metastatic non-small cell lung cancer who progress during or following platinum-based chemotherapy;
- for advanced renal cell carcinoma patients who received prior anti-angiogenic therapy;
- for patients with classical Hodgkin lymphoma who relapsed or progressed after autologous stem cell transplant and adjuvant Adcetris (bretuximab vendotin).
Bristol-Myers Squibb’s new application is based on data primarily from its open-label, single-arm, Phase 2 CheckMate-275 (NCT02387996) study, whose primary endpoint was objective response rate, and where durability of response and overall survival are also addressed. CheckMate-275 results will be presented at the upcoming 2016 European Society for Medical Oncology Congress, to be held in Denmark on Oct. 7–11.