DCGI orders withdrawal of cancer drug Olaparib for certain treatments
Hindustan TimesNew 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. HT Image 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. 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 patient with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. "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.
History of this topic
Cancer patients to receive ‘life-changing’ AstraZeneca drug through NHS
The Independent
Life-extending prostate cancer drug rejected for NHS
The IndependentDiscover Related
