Subcutaneous Herceptin recommended for approval in Europe
 

Roche's subcutaneous Herceptin gets EU green light

ZURICH, June 28 | Fri Jun 28, 2013 11:48am EDT

(Reuters) - Swiss drugmaker Roche said on Friday that European regulators had given a green light to a new formulation of its breast cancer drug Herceptin, which it hopes will help extend the medicine's shelf life.
The European Medicines Agency (EMA) said that its experts had recommended approval of a new injectable version of Herceptin, which cuts down treatment time to just two to five minutes. It currently takes between 30 to 90 minutes to administer the drug intravenously.
Herceptin, known generically as trastuzumab, is used as a treatment for around a quarter of breast cancer patients who have tumours that generate a protein called HER2, which tends to make their disease more aggressive.
Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. (Reporting by Caroline Copley, editing by Tom Miles)


www.reuters.com/article/2013/06/28/roche-herceptin-idUSWEB007EE20130628?feedType=RSS&feedName=rbssHea lthcareNews&rpc=43

Re: Subcutaneous Herceptin approved in Europe
 

Unfortunately your title may be misleading. It was recommended for approval--it still needs to be approved by the European Commission. I doubt they will go against the recommendation, as it is likely in the longterm to save money (since time is money) although for several years it may cost more if biosimilar herceptin gets going anytime soon in EU.

In any case, this approval will in all likelihood be forthcoming in a couple of months.

Re: Subcutaneous Herceptin approved in Europe
 

Thanks for the correction...I misread. I fixed it so it is not misleading.