Covering all the bases

Detailed Phase III data presented by Novartis AG at the American Society of Hematology meeting last week will provide the first test of whether regulators will accept major molecular response as a new endpoint for trials of compounds to treat chronic myelogenous leukemia.

The data will be used to support applications for the company's Tasigna nilotinib as first-line treatment for newly diagnosed Philadelphia chromosome-positive CML. Novartis plans to submit an sNDA to FDA and a Type II variation application to EMEA by month's end...