India's drug regulator orders withdrawal of AstraZeneca's cancer drug due to potential adverse effects

The Drug Controller General of India (DCGI) has asked all state drug regulators to withdraw AstraZeneca's anti-cancer drug Olaparib tablets. This drug which is mostly used for the treatment of patients with gBRCA mutation and advanced ovarian cancer and breast cancer has potential adverse effects, DCGI has said.

Olaparib tablets are a type of medication known as a PARP inhibitor or polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor, used primarily in the treatment of certain cancers, including ovarian, breast, pancreatic, and prostate cancers. They work by blocking the PARP enzyme, which helps repair DNA damage in cells. In cancer cells with specific genetic mutations like BRCA1 and BRCA2, this inhibition leads to cell death, slowing cancer progression. Olaparib is typically prescribed for patients with advanced cancers that have not responded to other treatments. Common side effects include nausea, fatigue, and anemia.

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... and submit the revised package insert. The drug may continue to be marketed for other approved indications," DCGI told state drug regulators.

The medicine was approved by DCGI in 2018 for treatment of patients for treatment of adult patients with ovarian cancer and certain forms of breast cancer.

“This decision of withdrawing the use of Olaparib as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy is justified,” Dr. Abhishek Shankar, Assistant Professor, Department of Radiation Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital at AIIMS, Delhi, told IANS.

The oncologist noted that “patients who were taking Olaparib potentially had a shorter overall survival than patients not on Olaparib, particularly in the subgroup analysis of patients who had received three or more lines of chemotherapy.

“So its use for this indication was withdrawn by the US FDA on March 26, so this order will certainly restrict the use of a drug which is found to be not efficacious for this indication.”

(With input from agencies)