ZURICH (Reuters) - Swiss drugmaker Roche said U.S. health regulators have granted a priority review of its Avastin drug when combined with chemotherapy to treat women with cervical cancer.
An approval by the U.S. Food and Drug Administration for treating advanced cervical cancer would open another large market for the medicine in patients for whom chemotherapy has been largely ineffective. About 4,000 women in the United States and 250,000 worldwide die each year from the disease.
“This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,” Sandra Horning, Roche’s chief medical officer and head of Global Product Development, said in a statement.
The approval follows a favorable study showing the drug helped prolong the lives of women with advanced cervical cancer when added to chemotherapy in a late-stage clinical trial, likely paving the way to another major use for the multibillion-dollar medicine.
Avastin, which is approved in the United States to treat a variety of cancers including colon, lungs and kidneys, recorded 1.565 billion Swiss francs ($1.75 billion) in revenue in the first quarter.
($1 = 0.8919 Swiss Francs)
Reporting by Katharina Bart; Editing by Michael Urquhart and Stephen Coates