The European Medicines Agency (EMA) has reversed its original negative opinion on Nerlynx (neratinib) for the adjuvant treatment of adult patients with breast cancer.
On 22 February 2018, the EMA’s Committee for Medicinal Products for Human Use (CHMP) decided against approving Nerlynx for extended adjuvant treatment of early-stage HER2-positive breast cancer. The decision was based on the findings of the ExteNET trial that found improved two-year recurrence-free survival. However, the CHMP determined that it remained uncertain whether the results would be replicated in clinical practice. The committee also expressed concern that the gastrointestinal side effects, particularly diarrhoea, which affected most patients, might be severe and difficult to manage.
At the request of the applicant, the CHMP initiated a re-examination of the opinion. Following the review, a positive opinion was adopted on 28 June 2018, but in a restricted patient population.
Nerlynx is expected to be used for adult patients with early-stage hormone receptor-positive HER2-overexpressed/amplified breast cancer who are less than one year from the completion of prior adjuvant trastuzumab-based therapy.
Detailed recommendations for the use of Nerlynx will be published in the European public assessment report (EPAR) after marketing authorisation has been granted by the European Commission.