Takeda’s PARP (poly ADP-ribose polymerase) inhibitor Zejula (ingredient: niraparib) expanded indication as monotherapy for patients who have been treated with chemotherapy regimens.
The drug had been initially indicated as maintenance therapy for platinum-sensitive progressive or metastatic ovarian cancer after chemotherapy.
The Ministry of Food and Drug Safety said it granted the nod for Zejula as monotherapy on Dec. 24 for patients with recurrent ovarian cancer who have been treated with three or more prior chemotherapy regimens.
With the approval, Zejula became the only PARP inhibitor in Korea to be used as monotherapy for those with BRCA-positive mutation regardless of platinum sensitivity or those who are platinum-sensitive, homologous-recombination deficiency (HRD)-positive among adults with recurrent ovarian cancer who have been treated with three or more prior chemotherapy.
The additional approval was based on the QUADRA trial.
In the study, Zejula showed an objective response rate at 24 percent in the platinum-sensitive and HRD-positive patient group, 39 percent in the platinum-sensitive and BRCA-positive mutation group, 29 percent in the platinum-resistant and BRCA-positive group, and 19 percent in the platinum-refractory and BRCA-positive group.
The median duration of response (mDOR) stood at 8.3 months in platinum-sensitive, HRD-positive patients. The safety profile was within a manageable level through dose adjustment.
Justin Kim, head of Takeda Oncology, Korea, said, “I am very pleased to hear that Zejula’s indication was expanded in the same month when the drug won the health insurance coverage so that we can provide the innovative treatment for more local ovarian cancer patients.”
As ovarian cancer often relapses, and patients have limited treatment options compared to other cancer patients, the expansion of Zejula’s indication will give an effective treatment option for those who experience multiple recurrences, he added.
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