FDA: The U.S. Food and Drug Administration today expanded the approved use
of Opdivo (nivolumab) to treat patients with advanced (metastatic)
squamous non-small cell lung cancer (NSCLC) with progression on or after
platinum-based chemotherapy.
Lung cancer is the leading cause of
cancer death in the United States, with an estimated 224,210 new
diagnoses and 159,260 deaths in 2014. The most common type of lung
cancer, NSCLC affects seven out of eight lung cancer patients, occurring
when cancer forms in the cells of the lung.
Opdivo works by
inhibiting the cellular pathway known as PD-1 protein on cells that
blocks the body’s immune system from attacking cancerous cells. Opdivo
is intended for patients who have previously been treated with
platinum-based chemotherapy.
“The FDA worked proactively with the
company to facilitate the early submission and review of this important
clinical trial when results first became available in late December
2014,” said Richard Pazdur, M.D., director of the Office of Hematology
and Oncology Products in the FDA’s Center for Drug Evaluation and
Research. “This approval will provide patients and health care providers
knowledge of the survival advantage associated with Opdivo and will
help guide patient care and future lung cancer trials.”
Opdivo’s
efficacy to treat squamous NSCLC was established in a randomized trial
of 272 participants, of whom 135 received Opdivo and 137 received
docetaxel. The trial was designed to measure the amount of time
participants lived after starting treatment (overall survival). On
average, participants who received Opdivo lived 3.2 months longer than
those participants who received docetaxel.
The safety and efficacy
of Opdivo to treat squamous NSCLC was supported by a single-arm trial
of 117 participants who had progressed after receiving a platinum-based
therapy and at least one additional systemic regimen. The study was
designed to measure objective response rate (ORR), or the percentage of
participants who experienced partial shrinkage or complete disappearance
of the tumor. Results showed 15 percent of participants experienced
ORR, of whom 59 percent had response durations of six months or longer.
The
most common side effects of Opdivo are fatigue, shortness of breath,
musculoskeletal pain, decreased appetite, cough, nausea and
constipation. The most serious side effects are severe immune-mediated
side effects involving healthy organs, including the lung, colon, liver,
kidneys and hormone-producing glands.
Opdivo for squamous NSCLC
was reviewed under the FDA’s priority review program, which provides
for an expedited review of drugs that treat serious conditions and, if
approved, would provide significant improvement in safety or
effectiveness in the treatment of a serious condition. Opdivo is being
approved more than three months ahead of the prescription drug user fee
goal date of June 22, 2015, the date when the agency was scheduled to
complete its review of the application.
The FDA previously approved
Opdivo to treat patients with unresectable (cannot be removed by
surgery) or metastatic melanoma who no longer respond to other drugs.
Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation's food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.