The Central Drugs Standard Control Organization (CDSCO) has issued a notification regarding the use of Olaparib Tablets (100mg and 150mg) for ovarian cancer treatment. This notification was dated May 16, 2024.
The initially approved use of Olaparib for advanced ovarian cancer in patients with a gBRCA mutation and who have received three or more prior chemotherapy treatments is being withdrawn.
This decision is based on new data suggesting a potential negative impact on overall survival for patients in this specific subgroup receiving Olaparib compared to chemotherapy.
Olaparib Tablets remain approved for other previously authorized indications, including maintenance treatment for ovarian cancer patients in remission after platinum-based chemotherapy.
Action for Manufacturers
All manufacturers of Olaparib Tablets are required to:
- Withdraw marketing for the specific indication
- Submit a revised package insert reflecting this change.
Healthcare professionals are advised to consult the updated prescribing information for Olaparib Tablets.
Patients currently taking Olaparib for the withdrawn indication should consult their doctor to discuss alternative treatment options.
