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Puma Biotech's breast cancer drug authorised by European Commission, despite prior concerns

Published on 05/09/18 at 11:55am

Puma Biotechnology have received European Commission marketing authorisation for Nerlynx (neratinib) despite prior concerns as to the safety and efficacy of the drug from the EMA.

The European Commission authorised Nerlynx 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.

The European Commission based its decision on data from a multi-centre, randomised, double-blind, placebo-controlled in which patients with HER2-positive breast cancer received either Nerlynx or a placebo for one year.

The trials showed that after two years, the rate of invasive disease-free survival was 95.3% in patients treated with Nerlynx compared with 90.8% in those receiving placebo.

However the drug was earlier rejected by the EMA after a trial showed just a 2% difference between Nerlynx and placebo as 94% of those receiving Nerlynx in comparison with 92% of those taking a placebo lived for two years without their disease returning to them. However the commission changed its mind after the American biotech submitted a re-examination request based on the results of the most recent trial. Nerlynx has also been approved in the United States since 2017.

Alan Auerbach, Puma Biotechnology President and CEO commented: “Reducing the risk of disease recurrence remains a need for patients, despite advances in the treatment of early stage HER2-positive breast cancer.”

He continued in saying: “We are pleased to bring this new medicine to patients in Europe and would like to express our appreciation to the patients, caregivers and physicians who contributed to the neratinib clinical development program and, more specifically, the ExteNET trial.”

Louis Goss

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