FDA Panel Votes Against Approving J&J's Liazal

The US Food and Drug Administration's Oncologic Drugs AdvisoryCommittee has voted against recommending approval of Liazal (liarozole fumarate), a drug for prostate cancer developed by Johnson & Johnson subsidiary Janssen Pharmaceutica.

The decision is a blow to the company, as analysts have predicted healthy revenues from the drug after approval. Prior to the panel meeting, Lehman Bros analysts said they felt the drug could make sales of more than $400 million within five years of registration, primarily because there are so few options for patients who fail first-line therapy.

The panel unanimously agreed that there were numerous defects in Janssen's trials of Liazal, a compound which raises endogenous retinoic acid levels and is intended for the treatment of advanced prostate cancer patients who are refractory to hormone therapy. Specifically, the company was criticized for changing the type of analysis of the data from that which was originally set out in the protocols, and not prospectively defining some of the endpoints it selected as proof of efficacy, namely time-to-progression, prostate-specific antigen levels and bone involvement.