QLT PhotoTherapeutic/Sanofi Photofrin
Executive Summary
Oncologic advisory committee will discuss application supplement (sNDA 20-451/03) for Photofrin (porfimer sodium) on the afternoon of Sept. 3 for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small-cell lung cancer. The company submitted a reanalysis of data for the indication after the committee voted against approval in September and a narrower NSCLC indication was granted ("The Pink Sheet" Jan. 12, T&G-15)