Neratinib was first approved in the US in July 2017.[1] However the eagerly awaited opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the future of the drug on the other side of the globe must have been disappointing for Puma Biotechnology.In January 2018 the CHMP returned a negative trend opinion regarding the Marketing Authorisation Application (MAA) for extended adjuvant treatment of early stage HER2-positive breast cancer, the same indication it is approved for in the US.[2]

In a press release, Puma Biotechnology explained that “A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe.” [2]

The company also explained that the EMA based the negative opinion on the phase III ExteNET[3] trial and the phase II CONTROL[4] trial. [2] The safety data from the ExteNET trial were used to support the successful approval of neratinib by the US FDA.[5]

For further information related to the first approval of neratinib please visit Drugs[6], or to learn more about the overall development of neratinib across all indications visit AdisInsight.[7]

Image credit: Alex Rodriguez-Santibanez

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