Will Zejula’s indication for 4th or more ovarian cancer treatments be deleted in Korea, too?

As poly ADP-ribose polymerase (PARP) inhibitors have recently seen their indications revoked or revised in the U.S., there is also a sign of changing approval details in Zejula (niraparib) in Korea, drawing the industry’s attention.

According to anonymous sources on Monday, Takeda Korea is now considering Zejua’s indication for the fourth or more treatment of ovarian cancer.

Takeda Korea is reportedly examining the voluntary withdrawal of the related indication to change its approval contents. It will discuss the matter with the Ministry of Food and Drug Safety, according to a company official wanting to remain anonymous, citing the company’s policy.

The source did not elaborate on the timing of making such an application.

However, the official made it clear that the company would limit the approval change to “fourth or more” ovarian cancer treatment, and there would be no changes in the primary and secondary maintenance treatment.

GSK, which holds the sales right of Zejula in the U.S., voluntarily withdrew the drug’s indication for a fourth or more ovarian cancer treatment in September.

Earlier, Clovis Oncology nullified Rubraca (rucaparib)’s indications for third and fourth ovarian cancer treatment, and AstraZeneca did the same for Lynparza (olaparib). Both drugs showed higher death risks in phase 3 clinical trials in the third or more treatment of patients with progressive ovarian trial than the control chemotherapy group.

Rubraca has yet to be introduced in Korea. Lynparza has entered here but has not received approval for an indication to treat a fourth or more treatment, requiring no separate measures to change approval content.

However, Zejula had received insurance benefits as a monotherapy for the fourth treatment of metastatic ovarian cancer patients with “BRCA mutations.”

Accordingly, if Takeda Korea voluntarily withdraws Zejula’s indication for a fourth or more ovarian cancer treatment, changes in reimbursement criteria will also seem inevitable.

Zejula also receives insurance benefits for secondary or more maintenance treatment. So if Zejula’s approved indication for secondary or more maintenance therapy is reduced to “gBRCA mutation patients,” it will also likely influence the drug’s insurance coverage.