BENGALURU: Puma Biotechnology Inc said on Tuesday 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.
Puma shares were up 27.5% at US$65.15 in premarket trading. They are down 48% this year through Monday close.
The decision followed a reexamination of the negative opinion announced by the Committee for Medicinal Products for Human Use in February, the company said.
The committee will hold a final vote at its next meeting, Puma said.
Last year, US 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 a tumour 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% to 25% of breast cancer cases.