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Big News: FDA Approves Opdivo (Nivolumab) for Lung Cancer

March 04, 2015

Opdivo® (nivolumab)

Today the FDA announced the approval of the immunotherapy Opdivo® (nivolumab) for the treatment of advanced squamous non-small cell lung cancer (NSCLC), making it the first immunotherapy approved for that indication. Opdivo was first approved in December 2014 for advanced melanoma. This most recent approval comes on the heels of very positive results from a phase III trial, which showed that lung cancer patients receiving Opdivo had superior overall survival compared to those receiving standard chemotherapy. Less than three months have passed since the trial ended—an indication of just how eager the FDA was to get this drug into the hands of patients.   

“This really is an exciting day for patients,” said Jill O’Donnell-Tormey, Ph.D., CEO and director of scientific affairs at the Cancer Research Institute (CRI). “Lung cancer is one of the deadliest cancers; having an effective immune-based treatment for this disease is huge. This also shows that immunotherapy can be a powerful approach to treat solid tumors that weren’t previously thought to be good candidates for immunotherapy.”

Opdivo, made by Bristol-Myers Squibb (BMS), belongs to a new class of immunotherapy drugs called checkpoint inhibitors. By “taking the brakes off” the immune response, these drugs allow a stronger immune attack against cancer. The specific braking molecule that Opdivo blocks is called PD-1, which is found on T cells. Cancer cells have the ability to step on this braking molecule and thereby deflect an impending immune attack. Opdivo prevents this interaction, so immune cells are free to go after the cancer and kill it. And, unlike traditional chemotherapies, checkpoint inhibitors like Opdivo offer the potential of long-term control of advanced disease, with far fewer side effects.

Opdivo is the third checkpoint inhibitor to be approved by the FDA since 2011, when Yervoy® (ipilimumab), also made by BMS, was approved for the treatment of advanced melanoma. Another PD-1 inhibitor—Keytruda® (pembrolizumab), made by Merck—was approved in September 2014 for the treatment of advanced melanoma that has stopped responding to other drugs.

The phase III BMS-funded trial that paved the way to FDA approval randomized 272 patients to receive either Opdivo intravenously every two weeks or the chemotherapy drug docetaxel intravenously every three weeks. The study was stopped early, in January of this year, because the results were clear: patients receiving Opdivo lived on average 3.2 months longer than patients receiving chemotherapy. While that might not sound like much, many of those who respond to the treatment end up having durable, long-term responses.


“There are so many milestones I‘ve been blessed to witness and attend thanks to this immunotherapy.”

– Maureen O’Grady


Some of the earliest lung cancer patients treated with Opdivo have spoken publicly about their positive experiences on the drug. Pam Griffith, 66, of Florida, achieved a full remission of her advanced lung cancer that failed to respond to chemotherapy. “I would not be alive today if were not for this drug,” she said in interview conducted last year; she is still alive and free of disease today.

Maureen O’Grady, 62, of Connecticut, who was featured in a CNN special last year, was also quick to express her gratitude. “There are so many milestones I‘ve been blessed to witness and attend thanks to this immunotherapy,” said O’Grady, who just this week celebrated her 41st wedding anniversary and whose two grandchildren were not yet born when she was treated but who are now age 4. 

Lung cancer is the leading cause of cancer-related deaths worldwide. More than 1.5 million people die each year of the disease, according the World Health Organization. NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases. Of these, about 25-30% are the squamous subtype—the specific subtype for which nivolumab has been approved. Lung cancer was once considered an unlikely target for immunotherapy, but recent experience with PD-1 checkpoint inhibitors have radically changed doctors’ views on the subject. 

Basic laboratory and clinical research funded by CRI was crucial in making this drug possible. CRI funded 6 postdoctoral fellows in four different laboratories working on the PD-1 pathway. In October 2014, CRI bestowed the William B. Coley Award—its highest honor—on the four scientists whose work established PD-1 as a new immune checkpoint that could be targeted with immunotherapy. 

To watch a video about how PD-1 works and the scientists behind its discovery, click here.

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