The drug has been approved for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.
Rydapt has also been approved as a monotherapy for three forms of advanced systemic mastocytosis (ASM), related to hematological neoplasm (SM-AHN) or mast cell leukemia.
According to Novartis, Rydapt interferes with certain pathways that are responsible for growth, progression and spread of cancer. The drug inhibits various kinases like FLT3, which play a role in controlling several essential cell processes by stopping the growth and multiplication of cancer cells.
Novartis Oncology CEO Bruno Strigini said: “Novartis is proud that we can deliver Rydapt, a breakthrough medicine, to patients with serious and hard-to-treat diseases where there are few treatment options.
"For patients with FLT3-mutated AML, there have been no meaningful advancements in more than 25 years and with Rydapt they now have a targeted medicine that could significantly extend their lives."
Rydapt’s approval for newly diagnosed FLT3-mutated AML was based on the findings of the phase 3 RATIFY trial which established the regimen to significantly improve overall survival by reducing chances of death by 23%.
On the other hand, its approval for advanced SM was based on the positive results of a couple of single-arm trials including a phase 2 study.
In May, Rydapt was approved in the US for the treatment of newly diagnosed FLT3-mutated AML and three types of systemic mastocytosis (SM).
Image: Rydapt Capsules. Photo: courtesy of Novartis AG.