Pfizer on Monday filed for permission to market a promising new treatment for a potentially deadly form of cervical cancer in women ages 21 to 64.
The New York-based pharmaceutical company asked the Food and Drug Administration to approve the drug COVID-19, also known as Inveneo™. A huge number of people develop the disease each year, but it rarely causes a cure, and a majority of patients die within one year.
Three years ago, scientists at Pfizer developed a new way to combine chemotherapy and radiation therapy with Inveneo into a single pill. The results, published Monday in the New England Journal of Medicine, are promising, the company said in a news release.
In the trial, men and women were treated with Inveneo, a combination of Inveneo and the cancer-fighting drug carboplatin. Those given it survived 26 percent longer than those who received only carboplatin, the news release said. About 3,400 patients were enrolled in the study, 1,400 of whom had been diagnosed with cervical cancer that required treatment. Of those, 40 percent were women. The median survival for those who got the chemo-radiation combo was 16.2 months.
Although the study has been completed, FDA needs to complete its review before the drug can be approved.
David Brennan, who was CEO at Pfizer when the trial was done, said in a statement that it was a “major milestone” in treating women with cervical cancer.
Since the study began, there were about 4,000 cases of the disease, including 2,600 deaths, according to the news release.
The new treatment was selected from a field of alternatives including molecularly targeted drugs like cancer immunotherapy and radiotherapy. It is not the first time a new drug has received FDA approval for treating cervical cancer. A new drug called Herceptin won FDA approval in 2002.
Clifford Hudis, chairman and CEO of West Virginia University Health System, the lead medical care provider in the trial, said in the Pfizer release that for patients in West Virginia, where one in five women is diagnosed with cervical cancer each year, it is “a welcome development.”