The European Medicines Agency's Committee for Medicinal Products for Human Use issued its day-180 list of outstanding issues as part of its ongoing regulatory review of Puma Biotechnology Inc.'s breast cancer drug Nerlynx.
Puma is seeking marketing authorization for Nerlynx for the extended adjuvant treatment of HER2-positive early stage breast cancer in patients who have previously been treated with Roche Holding AG's Herceptin.
The EMA committee requested additional data analyses related to the safety and efficacy of Nerlynx, also known as neratinib, and has instituted a clock stop in order to give the company time to respond to the list of issues.
Nerlynx received approval from the U.S. Food and Drug Administration for post-surgery treatment of adults with certain early-stage breast cancer after they have first been treated with Herceptin.
Puma expects the committee to issue an opinion regarding the marketing authorization application of the drug in the first quarter of 2018.
In addition, Puma said it has promoted Richard Bryce to the role of chief medical and scientific officer, effective Aug. 1. Bryce was previously senior vice president of clinical research and development at the company.