LONDON (Reuters) - Roche’s new breast cancer drug Kadcyla was approved in Japan on Friday and recommended for approval in Europe, building on February’s U.S. green light for the product.
Kadcyla is designed for patients with late-stage disease whose cancer cells contain increased amounts of a protein known as HER2.
It works by attaching Herceptin to a drug called DM1, developed by ImmunoGen, which interferes with cancer cell growth. ImmunoGen will receive a $5 million milestone payment from Roche following the Japanese approval.
The European Medicines Agency (EMA) said on Friday its experts had also recommended a prostate cancer medicine, Xofigo, from Algeta and Bayer, which is also already approved in the United States.
In addition, the EMA issued positive recommendations for Johnson & Johnson’s diabetes drug Invokana, Gilead’s HIV treatment Viteka, GlaxoSmithKline’s lung drug Relvar, AstraZeneca’s flu vaccine Fluenz Tetra, Novo Nordisk’s hemophilia drug NovoEight, Otsuka’s schizophrenia drug Abilify Maintena and a premature ejaculation therapy from Plethora Solutions.
Recommendations for marketing approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
Reporting by Ben Hirschler; editing by Keith Weir and Elaine Hardcastle