DCGI Orders Withdrawal of AstraZeneca’s Anti-Cancer Drug Olaparib for Certain Treatments

The Drug Controller General of India (DCGI) has instructed drug regulators across all states and Union territories to recall AstraZeneca's anti-cancer drug Olaparib tablets from the market. This directive specifically targets the use of the drug in patients who have undergone three or more prior lines of chemotherapy. 

State regulators have been directed to ensure that manufacturers cease the marketing of Olaparib tablets for the treatment of patients with gBRCA mutation, advanced ovarian cancer, and breast cancer. This action follows concerns regarding potential adverse effects associated with the drug. Manufacturers are also required to submit revised package inserts reflecting the updated guidelines.

The drug may continue to be marketed for other approved indications, the apex drug regulator said. In a communication dated May 16, the DCGI informed regulators that AstraZeneca Pharma India Limited has submitted an application requesting the withdrawal of indications for Olaparib Tablets 100mg and 150mg. These indications pertain to the treatment of patients with gBRCA mutation and advanced ovarian cancer who have undergone 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. The communication stated that the firm presented the clinical evidence for the withdrawal of indication of Olaparib tablets.

The communication further stated that the 100 mg and 150 mg tablets were initially approved by the DCGI on August 13, 2018, for the treatment of adult patients with ovarian cancer and specific forms of breast cancer.