(Reuters) – Puma Biotechnology Inc on Friday won a key recommendation from a European Medicines Agency panel on its lead breast cancer drug, five months after the regulator recommended against approving it.
Shares of Puma, which on Tuesday signaled the committee was likely to give positive opinion on the drug, neratinib, was up over 5 percent in light pre-market trading on the Nasdaq.
The decision follows a reexamination of the negative opinion announced by the Committee for Medicinal Products for Human Use in February.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months.
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.
The experimental drug lowers the risk of the disease returning after initial treatment.
The U.S. Food and Drug Administration already approved Puma’s drug last year.
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 Justin George Varghese and Sangameswaran S in Bengaluru; Editing by Shailesh Kuber