The Drug Controller General of India (DCGI) has instructed drug regulators in all states and Union territories to withdraw AstraZeneca's anti-cancer drug Olaparib tablets for patients who have undergone three or more prior lines of chemotherapy. State regulators are directed to ensure that manufacturers cease marketing the drug for treating patients with gBRCA mutation and advanced ovarian or breast cancer due to potential adverse effects. Additionally, manufacturers must submit a revised package insert. The drug may continue to be marketed for other approved indications, according to the apex drug regulator.
What did the DCGI say?
In a communication sent to the regulators on May 16, the DCGI stated that the firm AstraZeneca Pharma India Limited has submitted an application to them for the withdrawal of indications for Olaparib Tablets 100mg and 150mg in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
"Based on post hoc subgroup analysis indicating a potential detrimental effect on overall survival for Olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy. "The matter has been reviewed in consultation with SEC (Oncology) experts in a meeting held on 19.03.2024 and 20.03.2024 at CDSCO," the communication stated.
Firms directed to withdraw specific indications for Olaparib tablets
The communication stated that the firm presented the clinical evidence for the withdrawal of indication of Olaparib tablets. "In view of the above circumstances, you are requested to direct all the manufacturers of said drug under your jurisdiction to withdraw marketing of the product Olaparib Tablets 100mg and 150mg approved by your office and submit the revised package insert. The drug may continue to be marketed for other approved indications," it added.
The communication further added that the 100 mg and 150 mg tablets were initially approved by the DCGI on August 13, 2018 for treatment of patients for treatment of adult patients with ovarian cancer and certain forms of breast cancer.
(With PTI inputs)
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