FDA Panel OKs Corixa's Trial Design For Melanoma Vaccine
By OTESA MIDDLETON
Of DOW JONES NEWSWIRES
WASHINGTON -- A federal advisory panel supported Corixa Corp.'s (CRXA) plan Wednesday for the key study of its genetically engineered skin cancer vaccine Melacine.
The endorsement is important for Corixa to proceed because the Food and Drug Administration had considered requiring the company to compare Melacine with another product, Schering AG's (SHR) Intron A. Corixa instead plans to assign patients randomly after surgery to either receive Melacine or nothing.
The company seeks approval for the drug so that it may be sold in the U.S. to prevent additional melanoma tumors after surgery. The agency will consider the panel's recommendation on how the trial should be conducted and tell the company its decision.
Melacine has been sold in Canada since 2000. Corixa wanted the vaccine approved in the U.S. based on one study of 689 patients, which showed the drug worked in melanoma patients whose tumors expressed certain genes.
The agency said another trial was needed to confirm the benefit. The FDA convened a meeting of its cancer experts to review Corixa's proposed design for the additional trial.
There aren't any approved drugs for preventing relapse after surgery in such mid-stage patients, said Martin Cheever, vice president of medical affairs at Corixa. Intron A is approved for more advanced, malignant melanoma patients.
"This is clearly an unmet medical need," Cheever said during his presentation to the panel.
But it will be years before the FDA will be reviewing data to determine if it will approve Melacine.
"The first pivotal trial took 10 years and the second could take another decade," Cheever said.
Corixa wants to study patients with Stage Two melanoma, meaning that their tumors are between 1 millimeter and 4 millimeters. The company said more than 30% of patients in this stage of disease relapse within five years.
Pharmaceutical analyst Ira Loss, of Washington Analysis, said, "This went very well for the company."
Some panel members suggested Corixa design its study to look at overall survival, not just relapse-free survival. The panel said the company should also consider allowing more types of melanoma patients in the study so target patients can be enrolled quicker and the trial wrapped up sooner, said panel consultant Harold Y. Vanderpool, of the Institute for Medical Humanities at the University of Texas.
"The goal is to do the trials right and find better treatments as soon as possible," Vanderpool said.
Panelist Kathy Albain, professor of medicine at Loyola University Medical Center, called the data on Melacine "exciting."
"I'm just concerned it will be 10 years before we get an answer, if all goes well," she said. |
