Shares in Puma Biotechnology shot up nearly 30 percent on news that the firm’s breast cancer drug Nerlynx is now likely to get a green light from European regulators.
The group said the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive trend vote supporting approval of Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive hormone receptor-positive breast cancer.
This is particularly good news for the firm given that the CHMP initially rejected the drug back in February, prompting it to request a re-examination of the application.
At the time, the CHMP said that while trial data showed that a greater proportion of women given Nerlynx lived for two years without their disease coming back versus those given placebo (around 94 percent versus 92 percent, respectively), “it is uncertain that this difference in benefit would be seen in clinical practice.”
It also noted that the drug causes side effects in the digestive system, particularly diarrhoea, which affected most patients and could be difficult to manage.
But the CHMP seems to have had a change of heart, informing Puma of the positive trend vote following the re-assessment and that it intends to hold a final vote at its next meeting.
Nerlynx was approved in the US in July last year, on the back of data showing a 34 percent reduction in the risk of invasive disease recurrence or death versus placebo following one year of therapy.
Data from the ExteNET trial also demonstrated that, after two years of follow-up, invasive disease-free survival was 94.2 percent in patients treated with the drug compared with 91.9 percent in those receiving placebo.
According to Puma, Nerlynx addresses an unmet medical need given that up to 25 percent of HER2-positive early-stage breast cancer patients treated with Herceptin-based adjuvant therapy experience a recurrence of disease.