PARP Inhibitor Niraparib: Oral Tablet Formulation for Ovarian Cancer

Convenient New Tablet Formulation

• June 9, 2022

Takeda Pharmaceutical announced Japanese regulatory approval of niraparib oral tablet 100mg formulation for ovarian cancer patients. The approval was based on bioequivalence and dissolution studies confirming equivalence between the new tablet and existing capsule formulations.

Approved Indications

Niraparib is approved for:

• First-line maintenance therapy after initial chemotherapy in ovarian cancer
• Maintenance therapy in platinum-sensitive recurrent ovarian cancer
• Treatment of platinum-sensitive recurrent ovarian cancer with homologous recombination repair deficiency

Key Advantage Over Capsule

The niraparib capsule formulation requires refrigerated storage. The new oral tablet formulation can be stored at room temperature, improving convenience and patient compliance, particularly in resource-limited settings or during extended travel.

Clinical Significance

Since Japanese launch of niraparib capsules in 2020, Takeda reports extensive clinical experience managing treatment of newly diagnosed and recurrent ovarian cancer patients. The tablet formulation expands access and improves practical management of maintenance therapy.

Data Source

https://www.takeda.com/ja-jp/announcements/2022/ZEJULA/

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