On Wednesday, an advisory panel declared that FDA has rejected the use of Amgen Inc’s drug Xgeva, prescribed for delaying the prostate cancer progression to the bone, in order to minimize the possibility of wider use of the drug.
The FDA panel voted 12-to-1 that drug’s benefits didn’t outweigh the risk of developing a jawbone-damaging condition.
FDA already approved Xgeva for preventing fractures and related issues in advanced prostate cancer that has affected the bone, but the manufacturer is looking for further approval for drug’s use in delaying or preventing the spread.
In a clinical trial involving 1,432 males with prostate cancer on whom hormone therapy was ineffective, the drug showed potential in delaying cancer spreading to the bone for slightly more than 4 months.
But nearly 1 in 15 males developed osteonecrosis of the jaw after drug use.
Generally, recommendations of expert panels are followed by the FDA, which is planning to make a final decision by 26th April, 2012.
Members of the FDA panel questioned whether earlier use of drug actually benefited patients, as many didn’t experience any symptoms, but would experience any side effects related to drug.
However, the patient delegate on the panel voted in approval’s favor.
Amgen said Xgeva offers a significant benefit to patients with prostate cancer by avoiding disease spread to the bones, which is common.
In a statement after the voting, the company said, “We are looking forward to discuss the matter with the FDA as our application has been continuously reviewed by the health regulators.”
If the company gets wider approval for Xgeva, it would become the medication to delay cancer-spreading to the bones, Amgen said.
Amgen said that the company was also testing Xgeva’s safety and effectiveness in treating other cancers like lung, breast, and blood cancer.