* Kadcyla approved in Japan, recommended for approval in EU
* EU agency also backs Algeta/Bayer prostate cancer drug
LONDON, Sept 20 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
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 haemophilia 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