That could lead to a quandary for doctors who are already prescribing Thalomid for multiple myeloma.
Thalomid had been approved for leprosy the year before, but it very quickly became used mostly for myeloma.
But just because she played a key role in Thalomid's development doesn't prove that Celgene owes her a dime.
For instance, most use of Celgene 's (nadsaq: CELG - news - people ) Thalomid is off-label.
Within the next six months Celgene will likely win approval to market both Thalomid and Revlimid as treatments for multiple myeloma.
It took a median of 76 weeks for patients taking both Thalomid and dexamethasone, an existing chemotherapy, to see their diseases worsen.
Revlimid, Celgene's second biggest-selling drug, is basically an improved version of Thalomid.
When it received approval to sell the drug as Thalomid, Warren, N.
Revlimid is the chemical cousin and heir to Celgene's first drug, Thalomid, which is still probably better known by its generic name, thalidomide.
Celgene and Pharmion have been partners since 2001, when Pharmion began selling Thalomid in Europe and Celgene acquired an equity stake in the smaller company.
The new trial, which included 270 patients whose multiple myeloma was being treated for the first time, leaves little doubt about Thalomid's efficacy against the cancer.
Celgene 's (nasdaq: CELG - news - people ) Thalomid was approved to treat leprosy but is used mainly as a life-saving cancer medicine.
Richardson points out that Thalomid, Celgene's follow-up drug Revlimid and Velcade, from Millennium Pharmaceuticals (nasdaq: MLNM - news - people ) of Cambridge, Mass.
It was her husband's doctor, Bart Barlogie of the University of Arkansas Medical Center, who ran the first clinical trial to show Thalomid's effect in multiple myeloma.
In a tougher measure of efficacy that takes into account how long patients lived, called progression-free survival, Thalomid more than doubled the length of time patients lived, to 57 weeks.
"That's very impressive, " says Paul Richardson, a myeloma specialist at the Dana-Farber Cancer Institute who has worked on other Celgene-sponsored trials but did not participate in this Thalomid study.
So far, says Chief Scientific Officer David Stirling , Revimid does not cause such birth defects in New Zealand rabbits--the only animal model in which the Thalomid problem shows up.
Revlimid may not cause birth defects, but the FDA wants further data before freeing it from the tight restrictions that keep Thalomid from being used in women who are pregnant or who could become pregnant.
But though Thalomid is widely used by doctors to treat multiple myeloma based on preliminary data, it is approved by the U.S. Food and Drug Administration only to treat a skin condition associated with leprosy.
Revimid, in any case, was designed to be a more potent and safer version of Celgene's existing drug, Thalomid, which was linked to birth defects when used decades ago as an anti-nausea treatment during pregnancy.
According to Li, there are two other VEGF-targeted drugs in late-stage clinical trials: Neovastat, developed by Aeterna Laboratories (nasdaq: AELA - news - people ), and Thalomid, better known as thalidomide, which is being tested by Celgene (nyse: CELG - news - people ).
应用推荐