Based on the results of the state health technology assessment, the Center recommends considering the inclusion of the medicinal product ixazomib in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 2 prior lines of therapy and have remained sensitive to lenalidomide in the lists of medicinal products procured with state funds using the procedure of managed access agreements (MAAs).
The results of the clinical efficacy analysis demonstrate the superiority of the combination ixazomib+lenalidomide+dexamethasone compared with the combination lenalidomide+dexamethasone, namely in progression-free survival and overall survival, with a statistically significant difference in those patients who received at least 2 prior lines of therapy.
The results of the direct comparison in the phase III clinical trial were consistent with the results of the meta-analysis regarding progression-free survival in patients who had previously received 2 and 3 lines of therapy. The overall survival result in such patients indicated a slight advantage, without a statistically significant difference with the use of the combination of ixazomib with lenalidomide and dexamethasone.
Detailed information on the conclusion of the state HTA on the medicinal product ixazomib can be found on the Center’s website at https://surl.li/jhfrfd
For your information, multiple myeloma is a rare malignant disease of plasma cells (derived from B lymphocytes). The altered plasma cells accumulating in the bone marrow produce coarsely dispersed paraprotein, which circulates in the blood serum. The pathological tumor process leads to renal failure, hypercalcemia, bone fractures and anemia.
