ADVISORY COMMITTEE VOTES DOWN XINLAY
An FDA advisory committee has rejected Abbott Laboratories' experimental prostate cancer drug Xinlay, but the panel agreed the compound has potential and should be further studied.
In a unanimous vote, the FDA's Oncologic Drugs Advisory Committee said the agency should not approve Abbott's new drug application for Xinlay (atrasentan HCl), which is proposed to treat men with metastatic hormone-refractory prostate cancer (HRPC).
The panel agreed with an FDA review staff analysis that concluded the clinical data on atrasentan did not show an advantage over placebo. The studies failed to meet primary endpoints as well as secondary endpoints, which included overall survival and progression-free survival, the FDA analysis said.
Abbott officials argued the data showed the drug provides a clinically meaningful benefit for a subgroup of prostate cancer patients with metastatic HRPC. The benefits include a delay in the onset of a decline in pain-related quality of life measurements, Abbott said. The drug would be indicted only for those men whose cancer had spread to the bone, but for which symptoms were not yet apparent. The company also said the cardiovascular issues related to the drug could be easily treated with conventional drugs.
One adviser also said he would like prostate cancer patients to have more options. "Although, I would like them to have legitimate options, development of this drug, I think, would be slowed down if we were to approve it at this time," said Otis Brawley, a professor of oncology at Emory University School of Medicine.
Other FDA advisers also noted the data on the drug shows promise, and they urged Abbott to continue testing and developing the compound. "We have hopes for your drug and hope to see you again," said committee chairman Silvana Martino of the Keck School of Medicine at the University of Southern California.
Abbott officials noted they are conducting further studies on the drug.