CHMP calls for additional data analysis on neratinib

3 August 2017

Puma Biotechnology (Nasdaq: PBYI) saw its shares dip 1.4% to $87.95 in after-hours trading on Wednesday, after the US company revealed a delay in approval of its breast cancer drug neratinib.

It said that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued its Day-180 List of Outstanding Issues in the process of its ongoing regulatory review of Puma’s Marketing Authorization Application (MAA) for neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer in patients who have previously been treated with trastuzumab (Herceptin)-based adjuvant therapy.

The CHMP has requested additional data analyses related to the safety and efficacy of neratinib and has instituted a clock stop in order to allow Puma time to respond to this List of Outstanding Issues. The CHMP has set a deadline of December 22, 2017 for Puma to respond to the list. Puma expects the CHMP to issue an opinion regarding the MAA for neratinib in the first quarter of 2018.

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