Europe's regulators had approved a new formulation of Roche's breast cancer drug Herceptin which will slash the time needed to administer the blockbuster.

The European Commission has given the green light to a new injectable formulation of Herceptin (trastuzumab) for HER2-positive breast cancer. The subcutaneous formulation is administered in two to five minutes, rather than 30-90 minutes with the standard intravenous form.

The approval is based on data from the HannaH study which showed that the subcutaneous formulation was associated with comparable efficacy to Herceptin administered intravenously in women with HER2-positive early breast cancer and resulted in non-inferior trastuzumab plasma levels. Overall, the safety profile in both arms was consistent with that expected from standard treatment with Herceptin and chemotherapy.

Roche chief medical officer Hal Barron noted that more than 90,000 women in Europe are diagnosed with HER2-positive breast cancer every year and "we are pleased this new formulation of Herceptin may enable patients to spend less time in the hospital and more time getting on with their lives". The approval is good news for the company's Herceptin franchise, given that the original drug goes off patent next year.

The green light also provided a boost to Halozyme Therapeutics, as the subcutaneous formulation uses the US biotech's recombinant human hyaluronidase technology.