Neratinib (Nerlynx™): Negative opinion in the European Union

Neratinib (Nerlynx™): Negative opinion in the European Union

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. Continue reading “Neratinib (Nerlynx™): Negative opinion in the European Union”

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

The recent first global approval of abemaciclib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer”

Neratinib (Nerlynx™): First Global Approval – a new adjuvant option for HER2+ve breast cancer patients – but has it bottomed out before it’s begun?

Neratinib (Nerlynx™): First Global Approval – a new adjuvant option for HER2+ve breast cancer patients – but has it bottomed out before it’s begun?

The recent first global approval of neratinib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Neratinib (Nerlynx™): First Global Approval – a new adjuvant option for HER2+ve breast cancer patients – but has it bottomed out before it’s begun?”