BioCentury
ARTICLE | Clinical News

Tasigna misses third-line GIST endpoint

October 23, 2009 12:31 AM UTC

Novartis AG (NYSE:NVS; SIX:NOVN) disclosed in its 3Q09 earnings that Tasigna nilotinib missed the primary endpoint of progression-free survival in a Phase III trial for third-line treatment of gastrointestinal stromal tumors (GIST). As a result, the company will not seek regulatory approval for the indication. The BCR-ABL tyrosine kinase inhibitor is in a Phase III trial for first-line GIST and is approved as a second-line treatment for chronic and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). On Tuesday, the company said the drug met the primary endpoint in a Phase III trial for first-line treatment of chronic phase Ph+ CML (See BioCentury Extra, Tuesday, Oct. 20, 2009). ...