Puma Biotechnology announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has adopted a positive trend vote recommending the approval of the Marketing Authorisation Application, or MAA, for neratinib for the extended adjuvant treatment of early stage HER2-positive hormone receptor positive breast cancer. The decision follows a reexamination of the negative opinion announced by the CHMP at its formal meeting with the company to discuss the MAA on February 23. The CHMP communicated its intention to hold a final vote at its next meeting.
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