Puma shares jump as breast cancer drug approval seems likely
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.”
Read more: http://www.pharmatimes.com/news/puma_shares_jump_as_breast_cancer_drug_approval_seems_likely_1242144
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.”
Read more: http://www.pharmatimes.com/news/puma_shares_jump_as_breast_cancer_drug_approval_seems_likely_1242144