The Central Drugs Standard Control Organization (CDSCO) on May 16, 2024, issued a notification regarding the withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patients with gBRCA mutation and advanced ovarian cancer.
The following has been stated: -
•Based on post hoc subgroup analysis indicating a potential detrimental effect on overall survival (OS) for Olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy.
•It is directed that all the manufacturers of the mentioned drug are to withdraw marketing of the product that is Olaparib Tablets 100mg and 150mg which was once approved for the treatment of patients with gBRCA mutation and advanced ovarian cancer and who have been treated with three or more prior lines of chemotherapy indication.
•It is also informed to the manufacturers that they need to submit the revised package and the drug may continue to be marketed for other approved indications.
The detailed notification is given in the document below.
[Notification No. F. No. 12-07/18-DC]
