Roche has submitted two filings to regulators in the USA to allow its blockbuster Avastin to be combined with commonly-used chemotherapies in advanced breast cancer.

The Swiss giant’s Genentech unit has filed two supplemental Biologics License Applications to the US Food and Drug Administration for Avastin (bevacizumab) for the treatment of women who have not received chemotherapy for metastatic HER2-negative breast cancer. One sBLA is based on the Phase III AVADO study that investigated the drug in combination with docetaxel and the other comes from data produced by the late-stage RIBBON-1 trial evaluating Avastin in combination with a taxane or anthracycline-based chemotherapy or Roche’s own oral chemotherapy, Xeloda (capecitabine).

Both studies met their primary endpoints of improving the time women lived without the disease worsening, Roche noted. In the USA, Avastin is currently approved in combination with paclitaxel for first-line treatment of advanced HER2-negative breast cancer, a thumbs-up which, somewhat controversially, was granted under the FDA’s accelerated approval programme last year.

The company said it hopes that the data from AVADO and RIBBON-1 will help convert the accelerated approval to a full green light. Avastin is also approved on both sides of the Atlantic as a treatment for colorectal cancer, non-small lung cancer, renal cell carcinoma and in the USA it has also been cleared for glioblastoma.