Sprycel receives full approval for chronic myeloid leukemia

The FDA has granted full approval for Sprycel (dasatinib tablets, from Bristol-Myers Squibb), an oral tyrosine kinase inhibitor, for the treatment of adults in all phases of chronic myeloid leukemia (CML) (ie, chronic, accelerated, myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy, including Gleevec (imatinib mesylate, from Novartis).

Sprycel was originally approved under the accelerated approval regulations of Subpart H of the Food, Drug, and Cosmetic Act for new drugs for serious or life-threatening illnesses, based on its effectiveness on hematologic and cytogenic response rates in CML. The full approval is based on data from a Phase 3, randomized, open-label, dose-optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The primary endpoint was major cytogenic response (MCyR) (0–35% Ph+ metaphases, which combines both complete and partial responses).

A summary of results from the 167 patients who received SPRYCEL 100 mg once daily include:
  • 80% progression-free survival estimated rate at two years
  • 91% overall survival estimated rate at two years
  • 63% of patients achieved MCyR 
  • 93% of patients who achieved MCyR maintained that response for 18 months
Sprycel is already approved for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.

For more information call (800) 321-1335 or visit www.sprycel.com.