By Mary Welch
With a revised new drug application (NDA) at the FDA for a second indication for Photofrin (porfimer sodium), its light-activated drug against lung cancer, QLT PhotoTherapeutics Inc. won a unanimous recommendation for approval from the agency's Oncologic Drugs Advisory Committee.
Last September, QLT, of Vancouver, British Columbia, heard the same panel give the FDA a recommendation of Photofrin as a curative, early-stage lung cancer treatment, but the committee failed to vote on the drug as a palliative for late-stage lung cancer.
Now, the panel has advised expansion of the label to include the second indication.
"We redid the data, re-analyzed it and cleaned it up a bit, and everything went fine," said Julia Levy, the company's president and CEO.
Specifically, the committee voted to recommend approval of Photofrin for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small cell lung cancer.
In January, Photofrin was approved as a potentially curative treatment for early-stage micro-invasive lung cancer in patients who are not candidates for surgery or radiotherapy. In 1995, it was approved as a palliative treatment for certain patients with esophageal cancer.
Photofrin is administered intravenously, and drug molecules go through the bloodstream, collecting in and around the tumor cells. When Photofrin is activated by the non-thermal light from a laser, it produces toxic oxygen, which disintegrates the tumor cells.
Principal side effects include skin sensitivity to light for about 30 days (which occurs in all patients), and some patients experience inflammation at the treatment site, causing varying degrees of shortness of breath and coughing.
The company anticipates filing with the FDA in 2000 to market Photofrin to treat Barrett's esophagus syndrome, for which the drug is in Phase III trials.
"Right now the only treatment is to remove the esophagus, which is a very severe act," Levy said.
QLT, Canada's third largest biotechnology company in terms of market capitalization, raised $15 million in July to support development of Verteporfin, its light-activated benzoporphyrin derivative for age-related macular degeneration (ARMD).
The Phase III trial for ARMD includes 609 patients, with the final patient undergoing a 12-month checkup in early October. The trial should wind up by the end of the year or early 1999, and QLT plans an NDA submission in mid-1999. ARMD is the leading cause of adult-onset blindness and affects about 10 percent of the U.S. population.
"This is a very big indication for us, very big," Levy said. About 200,000 new cases of ARMD are diagnosed each year.
QLT's partner, Sanofi Pharmaceuticals Inc, of New York, the U.S. subsidiary of Paris-based Sanofi SA, will market Photofrin for the palliative lung cancer indication in the U.S.
"It won't be later than March 1999," Levy said. "The only thing that may delay the timing would be a discussion on the label claim."
QLT's stock (NASDAQ:QLTIF) closed Friday at $13.625, up $0.562. *