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Puma Biotechnology Receives Positive CHMP Opinion Recommending Approval of NERLYNX
Jun. 29, 2018 09:03AM PST
Biotech InvestingPuma Biotechnology (Nasdaq:PBYI) announced that on June 28, 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for the medicinal product NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year …
Puma Biotechnology (Nasdaq:PBYI) announced that on June 28, 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorisation for the medicinal product NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy.
As quoted in the press release:
The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Today’s decision is consistent with the CHMP’s positive trend vote, which was communicated to the Company on June 26, 2018.