Novartis: Tasigna is better than Glivec “in every measure”

Novartis has presented yet more late-stage data which reveals that Tasigna, its relatively new drug for chronic myeloid leukaemia, is more effective than the Swiss firm’s own blockbuster Glivec in newly-diagnosed patients.

Presenting at the American Society of Hematology meeting in New Orleans, the Swiss major unveiled full data from the first head-to-head comparison of the two oral therapies as as a first-line treatment for Philadelphia chromosome-positive CML patients. The 864-patient Phase III study, called ENESTnd, revealed that Tasigna (nilotinib) showed statistically significant improvement “in every measure” over Glivec (imatinib).

At 12 months, significantly fewer patients progressed to accelerated or blastic phase on Tasigna 300mg twice-daily than on Glivec 400mg once daily (two patients out of 282 versus 11 from 283). Also, fewer patients discontinued due to adverse events from Tasigna.

Novartis head of oncology, David Epstein, said that “considering the already low rates of progression to advanced disease and the excellent long-term survival of patients on Glivec, the efficacy and safety profile of Tasigna at 12 months is fantastic news”. The company will now seek expanded approval of Tasigna for patients with newly-diagnosed Ph+ CML; the drug is already available in over 80 countries for patients who have not responded to prior treatment and Novartis is confident it will become a blockbuster.