Federal approval of the highly-touted immunotherapy drug Opdivo for advanced squamous non-small cell lung cancer may signal good news for malignant pleural mesothelioma patients.
The U.S. Food and Drug Administration earlier this month granted accelerated approval to Opdivo, also known as nivolumab, after it showed an unprecedented ability to prolong the lives of lung cancer patients with metastatic disease.
Opdivo, marketed by Bristol-Myers Squibb Company, is designed to inhibit the protein on cells that blocks the body’s immune system from attacking the cancer. Immunotherapy, which most believe is the future of cancer care, involves triggering the body’s own immune system to fight off disease.
The drug has been a life-extender for many already.
“It’s the biggest breakthrough for lung cancer in recent history,” said scientist Raymond Wong, Ph.D., of the Pacific Heart Lung & Blood Institute in Los Angeles, a world leader in mesothelioma treatment and research. “It could signal a paradigm shift in the way many cancers are treated, including mesothelioma one day.”
Although the recent approval is only for lung cancer, mesothelioma patients may get access to the drug through the FDA’s expanded access exception if these conditions are met:
- If a doctor determines there is no comparable or satisfactory alternative therapy available, and the probable risk to the patient is not greater than the risk from the actual disease.
- The FDA determines there is evidence of the safety and effectiveness for this particular disease.
- The FDA determines that providing the drug will not interfere with a related clinical trial.
- The company developing the drug submits a clinical protocol for its use.
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Opdivo Tested in Several Cancer Clinical Trials
Researchers are testing Opdivo in numerous clinical trials involving several different cancers, although none involve mesothelioma, an aggressive and incurable rare disease.
The FDA approval for non-small cell lung cancer (NSCLC) came just two months after researchers ceased running a clinical trial three months ahead of its deadline because of its resounding success.
“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “This approval will provide patients and health care providers with knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”
It is intended for patients previously treated with platinum-based chemotherapy. It is the first immunotherapy drug approved by the FDA for NSCLC.
Opdivo was first approved in the U.S. in December of 2014 for patients with advanced melanoma.
Approval for NSCLC was based on a 41 percent reduction in the risk of death during a phase III clinical trial involving 272 participants. The median overall survival was 9.2 months, compared to just six month for patients given a comparable, chemotherapy drug with the same advanced cancer.
In other current trials, Opdivo also has shown a good response rate against kidney, bladder, and head and neck cancers.
Lung cancer is the leading cause of death from cancer in the U.S. Approximately 224,000 people were diagnosed last year. An estimated 160,000 people died from lung cancer in 2014.
Other Immunotherapy Drugs Are Coming Soon
According to a press release by Bristol-Myers Squibb, it has been 15 years since the FDA last approved a therapy for NSCLC that demonstrated superior overall survival compared to standard of care.
Rival pharmaceutical company Merck is expected to follow soon with a similar immunotherapy drug called Keytruda. It also has been approved for melanoma, but it still is in the clinical trial phase for NSCLC.
Both drugs target the same PD-1 protein that acts as a brake on the immune system’s ability to fight off various cancers.
“It [immunotherapy] is the hottest topic in cancer care today,” said Wong, who wrote his doctorate thesis on nivolumab more than a decade ago. “I’m not a fortune teller, but we thought at the time [of my thesis] that it would eventually be a breakthrough.”
Wong emphasized that even with the breakthrough of immunotherapy drugs, such as Opdivo and Keytruda, they likely will be used in conjunction with standard chemotherapy and radiation to harness the maximum effectiveness.
He authored an article in the American Journal of Respiratory Cell and Molecular Biology a year ago that provided the details of things to come.
“The most effective immunotherapy approaches might integrate multimodality regimens that also abrogate immunosuppressive circuits,” Wong wrote. “Radiation and chemotherapy may deplete tumor-promoting immunosuppressive cells, thereby creating a host environment more amenable to immunotherapy.”