Kadcyla ticks off first European approval
This article was originally published in Scrip
Roche's antibody-drug conjugate product Kadcyla (ado-trastuzumab emtansine) has been approved in Switzerland, its first European market.
Approved indication
It has been approved by Swissmedic for use in patients with HER-2 positive metastatic breast cancer who have previously been treated with Herceptin (trastuzumab) and a taxane-based chemotherapy.
Market size
Roche says there are more than 5,000 women diagnosed with breast cancer each year in Switzerland.
Other markets
Kadcyla was approved and launched in its first market, the US, in February and launched there the following month. It is also awaiting centralized EU approval, due later this year.
Licensing details
Kadcyla is comprised of Genentech's antibody Herceptin attached to ImmunoGen's potent cancer-killing agent DM1 using the latter firm's stable linker, which is designed to keep the drug in one piece until it reaches the specific cancer cells.
Links to previous stories:
Safety group forewarned about Genentech drug name confusion
INTERVIEW: ImmunoGen prepares to capitalize on Kadcyla
Genentech/ImmunoGen HER2-targeted drug T-DM1 crosses finish line early in US