Monday, April 11, 2022

Opdivo plus Cabometyx approved in the EU for advanced renal cancer




The European Commission (EC) has authorised Bristol Myers Squibb’s (BMS) Opdivo plus Ipsen’s Cabometyx as a first-line treatment for advanced renal cell carcinoma (aRCC).

The EU approval is based on results from the Phase III CheckMate-9ER trial, which evaluated Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in previously untreated advanced or metastatic renal cell carcinoma patients.

In this study, Opdivo plus Cabometyx doubled progression-free survival compared to patients receiving Pfizer’s tyrosine kinase inhibitor (TKI) Sutent (sunitinib) alone – 16.6 months versus 8.3 months respectively.

The Opdivo and Cabometyx combination also reduced the risk of death by 40% compared to the TKI inhibitor, and also demonstrated a superior objective response rate (ORR) – twice as many patients responded to BMS/Ipsen’s drugs compared to Sutent.

“Today’s EC approval for the use of Cabometyx in combination with Opdivo provides an important new first-line treatment option for patients living with advanced renal cell carcinoma,” said Howard Mayer, executive vice president and head of research and development, Ipsen.

“We look forward to collaborating with a broad range of European stakeholders to bring this unique combination to eligible patients living with advanced renal cell carcinoma,” he added.



Source link

Latest Articles

Widely used chemical linked to 1,00,000 US deaths per year: Study

NEW YORK: Daily exposure to phthalates, a group of chemicals used in everything from plastic containers to makeup, may lead to approximately 100,000 deaths...

Foods to Reduce Inflammation and Strengthen the Immune System

Did you know that you can greatly reduce inflammation and boost your immune system by simply incorporating more anti-inflammatory foods and beverages into your...

Personal Selling

INTRODUCTION Early sellers and traders were not held in high esteem. The Roman word for salesman meant ‘Cheater’ and...

Building Muscle on a Vegan Diet

There are a lot of  misconceptions surrounding veganism. The notion that those who practice it are lacking in protein and therefore muscles is the...

Electrodes in brain new hope for severe cases of epilepsy

Neurosurgeons at All India Institute of Medical Sciences have devised a new technique for operating on children suffering from a severe form of epilepsy...