In a recent order the Drug Controller General of India has asked for the drug Olaparib used for breast and ovarian cancer to be withdrawn
The Drug Controller General of India has asked for the withdrawal of AstraZeneca’s cancer drug Olaparib for patients who have already been given three or more prior lines of chemotherapy. The drug had originally been approved in 2018. The pharmaceutical company, based on its own analysis of the effects in patients who received the drug, had moved the DCGI for the withdrawal of the drug.
“The firm M/s. Astrazeneca Pharma India limited has submitted application to this directorate 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.
Based on post hoc subgroup analysis indicating a potential detrimental effect on overall survival (OS) for Olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy,” DCGI said in a recent order.
Olaparib was approved for adult patients with cancers of the outer layer of the ovary or the fallopian tube or cancer of the lining of the abdominal cavity. It was also used in ovarian and breast cancers associated with one or more genetic mutation when other lines of therapy had failed.
The drug controller said that aside of treatment of cancer patients with specific genetic mutations and advanced ovarian cancer who have been given three or more lines of chemotherapy, Olaparib Tablets 100mg and 150mg can continue to be used in other patients.
