A new drug that promises to be a potent treatment for advanced squamous non-small cell lung cancer has received the go signal of federal officials. The United States Food and Drug Administration has granted accelerated approval to Opdivo, also known as Nivolumab, after it has shown its potent ability to prolong the lives of lung cancer patients with metastatic disease.
The medicine was manufactured and developed by Bristol-Myers Squibb Co. They received the FDA approval three months ahead of the agency's deadline for reviewing the drug and just two months after the clinical trial of the said medicine. Due to its potency, the FDA fast tracked its approval for patients to be able to use it immediately, reports Wall Street Journal.
"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," said Richard Pazdur, head of hematology and oncology products at the FDA.
Meanwhile, Giovanni Caforio, the company's chief operating officer and chief-executive officer-designate noted, "This is an important day for cancer patients and an important day for Bristol-Myers. Studies showed Opdivo has the ability to nearly double the survival rate for patients which really says it can become the standard of care for this disease."
The company said that the initial price of the medicine will be at $12,500 a month or around $150,000 for patients who would use it for one year.
Opdivo works by interfering with a molecular brake named PD-1 that prevents the immune system from attacking tumors. Hence, the body will also help in attacking the tumors and killing them without further damaging the healthy cells of the body.
Raymond Wong, Ph.D., of the Pacific Heart Lung & Blood Institute in Los Angeles, a world leader in mesothelioma treatment and research said, "It's the biggest breakthrough for lung cancer in recent history. It could signal a paradigm shift in the way many cancers are treated, including mesothelioma one day."
