New Delhi: The Drugs Controller General of India has asked drug regulators in all states and union territories to withdraw AstraZenecaanti cancer drug olaparib pills for Treatment In patients Those who have received three or more prior lines chemotherapy. State regulators have been asked to direct the drug’s manufacturers to stop marketing the drug for treating patients with gBRCA mutations. advanced ovarian cancer And Breast Cancer A revised package insert must be submitted due to potential adverse effects.

The top drug regulator said marketing of the drug can continue for other approved indications as well.

In a communication sent to regulators on May 16, DCGI said firm AstraZeneca Pharma India Limited has submitted an application for them withdrawal Indications of Olaparib Tablets 100 mg and 150 mg In the treatment of patient with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

“Post hoc subgroup analysis indicated a potentially harmful effect of olaparib on overall survival compared with 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 the meeting held on 19.03.2024 and 20.03.2024 CDSCO“The communication stated.

The firm presented clinical evidence to withdraw the indication of Olaparib tablets, the communication said.

“In view of the above circumstances, you are requested to direct all manufacturers of the said drug under your jurisdiction to withdraw the marketing of the product Olaparib Tablets 100 mg and 150 mg approved by your office and submit a revised package insert. The drug may continue to be marketed for other approved indications.”

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 certain forms of breast cancer, the communication said.