DCGI Orders Withdrawal of AstraZeneca's Cancer Drug Olaparib for Some Treatments
Moneylife Digital Team 23 May 2024
The Drug Controller General of India (DCGI) has asked drug regulators in all states and Union Territories to withdraw AstraZeneca's anti-cancer drug Olaparib tablets for treatment in patients who have received three or more prior lines of chemotherapy.
 
In the order last week, DCGI has asked state regulators to direct manufacturers of the drug to discontinue marketing of Olaparib tablets 100mg and 150mg for the treatment of patients with germline breast cancer gene (gBRCA) mutation and advanced ovarian cancer and breast cancer due to potential adverse effects and submit the revised package insert.
 
On 13 August 2018, the Central Drugs Standard Control Organisation (CDSCO) approved Olaparib tablets 100mg and 150mg for the treatment of patients with gBRCA mutation and advanced ovarian cancer. 
 
AstraZeneca Pharma India Ltd submitted an application to withdraw the drug. The company also presented clinical evidence for withdrawing Olaparib tablets 100mg and 150mg.
 
After reviewing the application and clinical evidence, DCGI directed AstraZeneca to withdraw Olaparib tablets 100mg and 150mg and revise the package inserts. 
 
However, the drug may continue to be marketed for other approved indications, the apex drug regulator says.
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