Watch Washington today to see which way the drug approval winds blow. The FDA is expected to give Avastin the yea or nay for use against breast cancer. It's a big deal for drug maker Genentech, which is counting on boosting sales past the $2.3 billion Avastin brought in last year. It also could become a big deal, however, for every other company developing cancer meds.
The data in Avastin's favor relies on tumor growth, not survival term. In Genentech's trials, Avastin slowed down progression of breast cancer, but patients didn't live significantly longer. That lack of improvement in survival led an FDA advisory panel to vote 5-4 against the new use for Avastin. The committee said the benefits didn't outweigh Avastin's serious side effects.
An FDA approval could indicate a new way of thinking about cancer meds. If stopping tumor growth is enough for Avastin, then it could be enough for a host of other treatments. True, the agency has given the nod to two other breast cancer meds based on slowed disease progression--GlaxoSmithKline's Tykerb and Bristol-Myers Squibb's Ixempra--but they're only approved as second-line treatments. Genentech wants Avastin classed as a first-line med.
Whatever the FDA does today, experts say, will give some insight into its thinking about the disease progression versus survival time debate.
- see Genentech's release about a recent Avastin study
- check out the article in the Boston Globe