SUBCUTANEOUS HERCEPTIN APPROVED IN EUROPE

A new subcutaneous formulation of trastuzumab (Herceptin, Genentech/Roche) has been approved by the European Commission. The targeted therapy, considered a breakthrough when it was developed for the treatment of HER2-positive breast cancer, is usually administered intravenously.

For the usual intravenous administration, patients attend a hospital or clinic, and each infusion takes 30 to 90 minutes to administer. In contrast, the new subcutaneous formulation takes only 2 to 5 minutes to administer.

In addition, the subcutaneous formulation is administered as a 600 mg/5 mL fixed dose every 3 weeks. This simplifies administration by removing the need for reconstitution or dose calculation on the basis of body weight, according to the company.

"The shortened duration of administration with subcutaneous trastuzumab has the potential to save time for patients, physicians, and nursing staff," said Gustavo Ismael, MD, from Amaral Carvalho Hospital in Jaú, Brazil. As previously reportedby Medscape Medical News, Dr. Ismael headed a clinical study, published last year in the Lancet Oncology(2012;13:869-878), that showed that "subcutaneously delivered trastuzumab offers a valid alternative to existing intravenously delivered treatments."

In a comment that accompanied that clinical study, Jose Perez-Garcia, MD, and Javier Cortes, MD, from the Vall d'Hebron Institute of Oncology in Barcelona, Spain, suggested that subcutaneous administration could lead to the drug being used at home, allowing patients to lead their lives "with less hospital dependence, which is an important psychological aspect."

"More than 90,000 women in Europe are diagnosed with HER2-positive breast cancer every year," said Hal Barron, MD, Roche's chief medical officer and head of global product development. "We are pleased this new formulation of [trastuzumab] may enable patients to spend less time in the hospital and more time getting on with their lives."

The subcutaneous formulation uses technology developed by Halozyme Therapeutics. It involves the use of recombinant human hyaluronidase, which temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin. This enables the 5 mL volume of the subcutaneous formulation of the drug to be rapidly dispersed and absorbed over a greater area, according to a Roche media release.

Since trastuzumab was first approved in 1998, it has been used to treat more than 1.3 million patients worldwide, the release noted.

A report on the PMLive pharma news Web site noted that the approval of the new version of trastuzumab will give Roche a boost before the drug's patent expires in Europe, in 2014, and cheaper biosimilar versions of the drug start to compete for sales.