Puma Biotechnology Inc said a committee of the European Medicines Agency was likely to give a positive opinion on its breast cancer drug, five months after the regulator recommended against approving it.
The decision followed a reexamination of the negative opinion announced by the Committee for Medicinal Products for Human Use in February, the company said.
Last year, U.S. Food and Drug Administration approved Puma’s drug, neratinib, that lowers the risk of the disease returning after initial treatment.
Neratinib is designed to treat early-stage breast cancer in patients with the HER2 genetic mutation in which the tumor has been surgically removed, and had been previously treated with Roche’s Herceptin.
Breast cancer is the most frequently diagnosed cancer in women, with HER2-positive breast cancer accounting for 20 percent to 25 percent of breast cancer cases.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Anil D’Silva and Shailesh Kube)