EMA accepts Bristol-Myers Squibb Opdivo Class II change application

Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) has accepted an application for class II changes to the anti-PD-1 therapy Opdivo (Nivolumab, generic name: nivolumab), and has initiated it Intensive review process: Opdivo is used as an adjuvant (postoperative) therapy to treat patients with high-risk muscle invasive urothelial carcinoma (MIUC) who have undergone surgical resection.

If approved, Opdivo will be the first adjuvant immunotherapy program for the treatment of MIUC in Europe.

MIUC patients often undergo major surgery to remove the bladder as a life-saving measure, but the probability of their cancer recurrence is still around 50%.

CheckMate-274 is a randomized, double-blind, multi-center study conducted in MIUC patients who have a high risk of recurrence after radical surgery.

The results showed that: (1) In all randomized patients (ITT), compared with placebo, adjuvant Opdivo treatment almost doubled the disease-free survival: the median DFS in the placebo group was 10.

In addition, Opdivo also showed improvements in key secondary endpoints, including non-urothelial relapse-free survival (NUTRFS), defined as the patient's survival time without recurrence outside the bladder, ureter, or renal pelvis.

In this study, the safety of Opdivo is consistent with previously reported solid tumor studies.

Bladder cancer is the tenth most common cancer in the world.

Most UC is diagnosed at an early stage, and the purpose of early treatment of MIUC is to reduce the risk of disease recurrence or spread to other parts of the body.

It is worth mentioning that CheckMate-274 is the first and only phase 3 trial, showing that in patients with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after radical surgery, an immunotherapy is used for Adjuvant (postoperative) treatment reduces the risk of disease recurrence.

By transferring immunotherapy to the early stages of cancer, there is an opportunity to interrupt the course of the disease, reduce recurrence, and bring a better prognosis for patients.

Opdivo belongs to PD-(L)1 tumor immunotherapy, which aims to use the body's own immune system to fight cancer, block the PD-1/PD-L1 signaling pathway to kill cancer cells, and has the potential to treat many types of tumors.

In China, Opdivo was approved for listing in June 2018, becoming the first approved immuno-oncology (IO) therapeutic drug in the Chinese market.

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Original source: European Medicines Agency Validates Bristol Myers Squibb's application for Opdivo (nivolumab) as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma