Company AstraZeneca announced that in Russia the registration certificate for calibrating intended for the treatment of chronic lymphocytic leukemia/small cell lymphocytic lymphoma (CLL/MLL) and relapsing/refractory (R/R) form multinacional lymphoma (MCL).
Calibrating is a new highly selective inhibitor of TKB second generation. This drug does not inhibit other tyrosine kinases, particularly EGF, ITK or TEC, so the clinical efficacy of the drug in trials was accompanied by the development of a smaller quantity unwanted effects such as bleeding and arrhythmias.
Approval of the drug in Russia was obtained on the basis of results of randomized clinical phase III studies (ELEVATE TN, CLL 1st line; ASCEND, R/R form of CLL; ACE-LY-004, R/R form ΜL).
In the reference study of the drug in first line therapy of CLL ELEVATE-TN, calibrating showed a statistically and clinically significant improvement in survival without progression (VBP) in patients receiving the drug in combination with aminotetralin or as monotherapy in comparison with standard therapy. The risk of disease progression or death in the combination therapy group with calibratiion decreased by 90% and in the group of monotherapy with calibration ― 80%. In the study, ASCEND (R/R CLL), the drug also showed high efficiency in comparison with the modes idealism with rituximab and bendamustine with rituximab: the estimated survival rate during the year without progression was 88% relative risk reduction of progression or death was 69%, the overall survival rate during the year was 94%.
Study of ACE-LY-004 was the registration for the readings of R/R MCL. The use of calibrating patients with the given pathology ensured a high frequency of long responses (frequency the overall response rate was 81%, and by the 12th month duration of response was 72%), estimated overall survival at one year was 87% with a median VBP not achieved.