Puma Biotechnology’s breast cancer drug approved in Europe

Puma Biotechnology received European Commission (EC) marketing authorisation for Nerlynx (neratinib) in breast cancer, despite earlier European Medicines Agency (EMA) efficacy and safety concerns.

Nerlynx has been authorised 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 EC based its decision on data from a multi-centre, randomised, double-blind, placebo-controlled3 ExteNET trial of Nerlynx following adjuvant to currently approved Herceptin (trastuzumab) treatment.

Patients with early stage HER2-positive breast cancer and within two years of completing Herceptin therapy were randomised to receive either Nerlynx or placebo for one year.

The results demonstrated that after two years of follow-up, invasive disease-free survival was 95.3% in patients treated with Nerlynx compared with 90.8% in those receiving placebo.

The most common side effects were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection.

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

“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.”

Puma had a rocky start to this approval, when the drug faced negative opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) in February this year. Data presented to the committee at this time showed very narrow drug benefits over placebo with 94% of women in its pivotal study living for 2 years without their disease coming back, compared to 92% on placebo.

The CHMP members were “uncertain that this difference in benefit would be seen in clinical practice,” and advised against the approval.

The committee changed its mind at the end of June, after the US biotech submiteed a re-examination request backed with new data from the phase 3 trial showing a significant efficacy difference.

Nerlynx has already been approved in the US as Neratinib since July 2017. It will be available on European markets in 2019, the firm said, starting from the launch in Germany in the first half of next year followed by other countries in the second.

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