From: WSJ

The Food and Drug Administration questioned whether Schering Plough Corp.'s (SGP) Pegintron drug provided enough benefit in patients with advanced melanoma to warrant approval.

Pegintron, an injection already approved to treat liver disease, faces a review by Monday by an outside panel of medical experts who serve on the agency's oncologic drugs advisory committee.

The FDA posted a review of the Pegintron on its Web site Thursday in advance of the panel meeting. The agency said while the drug, given to patients after surgery to remove cancer, improved relapse free survival, or the time before the cancer returned, it didn't improve overall survival. The agency also said the drug carried "substantial toxicity" that included blood disorders, fatigue and abnormal liver function tests.

The agency said the key issue for the application is whether an improvement in relapse-free survival "in the absence of an improvement in overall survival is evidence of a direct clinical benefit that outweighs the toxicity" of treatment with Pegintron.

Schering Plough, in a document also posted to FDA's Web site, said Pegintron resulted in an average of a 9.2-month improvement in regression-free survival.