Avastin filed for first-line breast cancer use in Japan
This article was originally published in Scrip
Roche's Japanese subsidiary, Chugai, has filed for the approval of the anti-VEGF monoclonal antibody drug Avastin (bevacizumab) for the first-line treatment of advanced or recurrent breast cancer.
The anti-angiogenic therapy was first approved in Japan in April 2007 for the treatment of unresectable advanced or recurrent colorectal cancer, and is currently awaiting approval for non-squamous non-small cell lung cancer.
In line with regulatory clearances elsewhere, the new Japanese submission is for Avastin's use in combination with standard chemotherapy. The product was approved in the EU for the first-line treatment of metastatic breast cancer in combination with paclitaxel in March 2007, and in the US (an accelerated approval) for locally recurrent or metastatic HER-negative disease – again in combination with paclitaxel – in February 2008.
The filing includes data from an international Phase III trial in the first-line setting, which showed a significant improvement in progression-free survival, and was supported by confirmatory efficacy and safety data from a Phase II Japanese trial, Chugai noted. Avastin did not show a survival benefit in the pivotal E2100 trial used to support EU and US approvals (scripnews.com, February 27th, 2008).
The incidence of breast cancer has been increasing in Japan, and the company pointed to one local study predicting that the number of new patients could top 45,000 next year.
GlaxoSmithKline's small molecule dual EGFR/HER2 inhibitor Tykerb (lapatinib) was launched as a second-line therapy for recurrent or non-operable metastatic HER2-positive disease in Japan earlier this year, for use in combination with Chugai's Xeloda (capecitabine). Chugai's own HER2-targeted Herceptin (trastuzumab) was approved for adjuvant use in breast cancer in Japan in February last year.