Puma Biotechnology Inc had a good day on Monday when its stock went up 35% as FDA staff posted briefing documents that will be used by the experts on the panel as the basis for discussion, that will be on 24th May, to review will review the company’s breast cancer drug, neratinib.
According to these documents the breast cancer drug neratinib appears to be effective, however a preliminary review by the U.S. Food and Drug Administration also brought up several issues that could make the drug fail the panel.
The review, posted on Monday on the FDA’s website, sent the company’s shares up as much as 84 percent to $69.35 from $37.80 before dropping back to $53.75 in afternoon trading.
Puma is applying to sell the drug for use in women who have already had their cancer surgically removed, and who have also been treated to keep it from coming back with Roche’s Herceptin.
If it will be approved the new breast cancer drug will be marketed under the brand name Nerlynx.
In a big clinical trial, it neratinib reduced the rate of breast cancer recurrence within two years by a third.
It found that after two years, about 94.2 percent of patients taking the neratinib were alive without their disease progressing, compared with 91.9 percent taking a placebo.
However, neratinib has a main safety concern, as 95 percent of patients were affected with diarrhea.
As Forbes reports, Chris Shibutani, Cowen’s biotech analyst, said the odds were slightly in Puma’s favor for Wednesday meeeting, which could become a nail-biter meeting for Puma investors. And furthermore, even after that, there’s a bigger question: will doctors and patients want this drug?