NICE rebuffs Avastin in breast cancer

The U.K.'s NICE issued a final appraisal determination recommending against Avastin bevacizumab from Roche (SIX:ROG; OTCQX:RHHBY) in combination with a taxane for first-line treatment of metastatic breast cancer. The FAD is in line with a July preliminary appraisal. NICE said Avastin offers limited and uncertain benefit for breast cancer patients compared with existing treatments. EMA's CHMP began reviewing the benefit-risk profile of Avastin in the indication in September.

The mAb against VEGF is approved in the EU and U.S. for metastatic breast cancer, metastatic colorectal cancer, unresectable or metastatic non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC), as well as for glioblastoma multiforme (GBM) in the U.S. In July, an FDA panel recommended removal of the first-line HER2-negative metastatic breast cancer indication from Avastin's label, for which it has accelerated approval. Two sBLAs for Avastin in the indication seeking to include use in combination with additional chemotherapeutics are under FDA review, with a PDUFA date of Dec. 17. ...