Puma Biotechnology Inc.'s announcement on Jan. 23 that its new anticancer kinase inhibitor and lead product, neratinib, was unlikely to receive a positive opinion from the EU's top advisory panel, the Committee for Medicinal Products for Human Use (CHMP) came as a surprise to commentators and showed, once again, that regulatory approval in one major market may not automatically translate into approval in another.
Neratinib oral tablets (Nerlynx) were approved by the US FDA in July 2017, but Puma reported on Jan. 23, 2018...