Roche's subcutaneous formulation of Herceptin cleared in Europe

Roche said Monday that the European Commission approved a new subcutaneous formulation of Herceptin (trastuzumab) for the treatment of HER2-positive breast cancer. The company noted that the subcutaneous formulation, which is authorised for both early and later stages of treatment, is administered in two to five minutes, rather than 30 to 90 minutes with the standard intravenous formulation.

The regulator's decision was based on results from the HannaH study, which showed that the subcutaneous formulation of Herceptin was associated with comparable efficacy to the intravenous drug in women with HER2-positive early breast cancer and resulted in non-inferior trastuzumab plasma levels. Roche noted that the safety profile in both arms of the HannaH study was consistent with that seen from standard treatment with Herceptin and chemotherapy and no new safety signals were identified.

Herceptin, which starts to lose patent exclusivity next year, generated sales of 3.1 billion Swiss francs ($3.3 billion) in the first half of the year. The subcutaneous version of the product was developed using technology gained through an agreement with Halozyme Therapeutics, which Roche noted temporarily and reversibly degrades hyaluronan, allowing the subcutaneous formulation of Herceptin to be rapidly dispersed and absorbed over a greater area.

For related analysis, see ViewPoints: Momentum grows for revamped Herceptin franchise.

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