It's nice to see Johnson & Johnson
A committee of experts recommended 14-1 that the Food and Drug Administration not approve Johnson & Johnson's cancer drug, Yondelis, because the benefits don't outweigh the risks.
Johnson & Johnson's press release response? "The committee provides non-binding recommendations based on its evaluation. The final decision regarding approval of the drug will be made by the FDA."
While technically true, I'll be shocked if the agency goes against the panel's recommendation. It's done so in the past, but it seems that it's usually the FDA rejecting a drug after the committee recommends it -- Dendreon's
Yondelis' problem is a combination of bad side effects and preliminary efficacy data. Considering that it treats cancer, the drug might have been able to overcome the side effect issues -- it seems to increase blockages in pulmonary arteries, cardiac adverse events, and liver enzymes (a sign of potential liver damage) -- but the data only showed a six-week increase in progression-free survival (PFS), a measure of when the tumor starts growing again. PFS is a reasonable surrogate endpoint for actual survival, which is what patients actually care about, but it's not enough to overcome the bad side effect profile. Plus, there are other drugs to treat ovarian cancer, like Bristol-Myers Squibb's
Assuming the FDA rejects Yondelis, there's still potential for the drug to make it to market. Overall survival data from the ongoing trial might be enough to get the drug over the risk-reward hump. Unfortunately that's still 18-24 months away.
Take a cue from Johnson & Johnson and keep your chin up, Fools. Just don't factor any Yondelis sales into your valuation models.
This Foolishness was recommended by a committee of monkeys in the game room:
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