Feb 13 2008
A new study on the cancer drug Avastin has found that when the drug is combined with chemotherapy it slowed down the progression of breast cancer.
Avastin which is also known as bevacizumab, is already approved in the United States and Australia as a treatment for colorectal and lung cancers and the successful results of the study will boost the drug's chances of being approved to treat breast cancer by the U.S. Food and Drug Administration (FDA).
Avastin is made by the biotechnology company Genentech Inc and is the company's best-selling drug.
Genentech says results of the late-stage study support Avastin's potential as a breast cancer treatment.
In the study Avastin was used in combination with paclitaxel chemotherapy and the researchers say no new safety problems related to Avastin emerged.
In December an FDA advisory panel in December narrowly rejected granting approval for Avastin to be used to treat breast cancer on the grounds that data from a previous study were insufficient to establish a favorable risk/benefit analysis for the drug's use in this patient population.
The panel said the drug's effectiveness in slowing the progression of the disease did not outweigh the drug's toxic side effects, especially since women getting Avastin did not live any longer.
Genentech says they are pleased that a second Phase III study with breast cancer patients showed a significant improvement in progression-free survival and also demonstrated Avastin's potential with a different chemotherapy.
In the study Avastin was tested at two doses in combination with docetaxel involving 736 patients, who had not received prior chemotherapy; at both doses, Avastin showed statistically significant improvement in the time patients lived without their disease advancing, compared to patients who received chemotherapy and a placebo.
However some analysts say the study has not yet shown that the drug lengthens lives and without survival data the new trial would not increase the chance for Avastin's approval this month.