DJ News Release on Laserscope's Partner QLT before FDA...
FDA Says QLT's Photofrin Has Benefit, But
More Toxicity
By Anita Womack
BETHESDA, Md. (Dow Jones)--Reviewers for the Food and Drug
Administration told an independent panel that QLT PhotoTherapeutics Inc.'s
(QLTIF) Photofrin has clinical benefit, but more toxicity than treatment it was compared to.
QLT filed a supplemental new drug application to the FDA seeking to use Photofrin to reduce the obstruction and palliation of symptoms in patients with obstructing endobronchial nonsmall cell lung cancer (NSCLC), also for the treatment of endobronchial carcinoma in situ or microinvasive NSCLC in patients for whom surgery and radiotherapy are not indicated.
Dr. Grant Williams, a reviewer for the FDA, told members of the Oncologic Drugs Advisory Committee that he had problems with the study designs.
Williams said 50% of patients in each study for the first indication had luminal responses after day 18. Williams added that 32% of the patients had clinically important benefit. However, he added that the efficacy findings were numerically superior to those on Nd:YAG, but the statistical comparisons were suspect. Nd:YAG is a thermal laser treatment that was directly compared to QLT's Photofrin. In terms of safety data, Williams said there were more photsensitivity, dyspnea, bronchitis and psychiatric incidents reported in the Photofrin arm.
Williams told the panel that in terms of symptom improvement for the first indication, Photofrin seems to beat out Nd:YAG, but there is 26%-28% missing data in the Photofrin group and 41%-44% missing data in the YAG group.
The one month cutoff of data did favor Photofrin, Williams said.
Photofrin has already been approved as a treatment for lung and esophageal cancer in France and the Netherlands; for esophageal cancer in the U.S.; for esophageal and bladder cancer in Canada; and for early-stage lung cancer, superficial esophageal cancer, superficial and early-stage gastric cancers, early-stage cervical cancer, and cervical dysplasia, a pre-cancerous condition, in Japan. |
