NEW DELHI: The Drug Controller General of India 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.
State regulators have been asked to direct manufacturers of the drug to discontinue marketing of the drug for the treatment of patients with gBRCA mutation and advanced ovarian cancer and breast cancer due to potential adverse effects and submit the revised package insert.
The drug may continue to be marketed for other approved indications, the apex drug regulator said.
