FDA Panel's Limited OK On QLT's Photofrin Confuses

In a "give with one hand and take with the other" situation, the US Foodand Drug Administration's Oncological Drugs Advisory Committee earlier this month recommended extending the indications for QLT PhotoTherapeutics' photodynamic drug Photofrin (porfimer sodium) to include early-stage lung cancer.

However, the panel did not vote on approval for advanced- or late-stage lung cancer. This promptly led to investor confusion, and QLT's stock price dropped. Photofrin is already approved to treat esophageal cancer in the USA, and QLT has said that the panel did not vote on late-stage approval because it did not feel the data presented was adequate. The product is sold in the USA by Sanofi.

Specifically, the committee voted in favor of approving Photofrin for the treatment of endobronchial microinvasive non-small cell lung cancer in patients for whom surgery and radiotherapy are not indicated.