New Cancer Immunotherapy Opdivo Approved by FDA

I’m writing—for the second time in six months—to share fantastic news:  just hours ago the FDA approved a powerful new immunotherapy for the treatment of cancer. The drug, called Opdivo® (nivolumab), has been making waves in clinical testing for months, and today it becomes available for melanoma patients. 

Opdivo, made by Bristol-Myers Squibb (BMS), belongs to a class of immunotherapies called checkpoint inhibitors. These drugs “take the brakes off” the immune response to cancer, and represent a truly breakthrough way of treating cancer.

BMS’s Opdivo is the second FDA-approved checkpoint inhibitor targeted at an immune protein called PD-1 (the other is Merck’s Keytruda®, approved in September of this year). Opdivo is FDA-approved for treating metastatic melanoma in patients who have failed prior treatment. Ongoing studies suggest it may benefit patients with many different cancers, including lung, brain, head and neck, stomach, and kidney cancers.

In addition to my excitement over what this FDA approval means for patients, I am extremely gratified to share that the Cancer Research Institute played an important role in making this drug possible:

• CRI funded the work of three scientists—Arlene Sharpe, Gordon Freeman, and Lieping Chen—whose research was crucial in establishing PD-1 as a new checkpoint that could be targeted with immunotherapy. These three scientists, along with Tasuku Honjo, shared the 2014 William B. Coley Award, the highest honor that CRI bestows.

• Jedd D. Wolchok, of Memorial Sloan Kettering Cancer Center and Ludwig Cancer Research—who is the associate director of our Scientific Advisory Council and director of our clinical trials network—was a principal investigator for the phase I clinical trial that established the safety and efficacy of nivolumab in patients with advanced melanoma.

• This past October, CRI honored Bristol-Myers Squibb with our Oliver R. Grace Award for their pioneering work to develop checkpoint blockade into a powerful new way to treat cancer. Opdivo is the second checkpoint inhibitor made by BMS to receive FDA approval, following the approval of Yervoy® (ipilimumab) in 2011. 

Immunotherapies like Opdivo (nivolumab) are radically changing the treatment odds for patients with cancer. With this new drug approval, we have moved one step forward to creating a world where cures are not only possible, but probable.

I wish to extend a heartfelt thank you to all our supporters, whose generosity helps us bring lifesaving cancer immunotherapy treatments to patients faster. Please consider making a donation to CRI to keep the momentum going.