Drug regulator to withdraw Olaparib, doctors concur

NEW DELHI: Oncologists supported the Drug Controller General of India’s (DCGI) mandate to state authorities to withdraw AstraZeneca’s anticancer generic drug, Olaparib, over safety concerns on Thursday.

Olaparib is a chemotherapy drug which is used to treat certain kinds of cancers relating to the ovaries, breasts, pancreas and the prostate.

In a letter dated May 16, Dr Rajeev Singh Raghuvanshi of DCGI, wrote to state drug regulators to discontinue marketing AstraZeneca’s Olaparib tablets (100mg and 150mg) sold as Lynparza, due to its potential adverse effects on some patients who have received three or more prior lines of chemotherapy.

According to health experts, the drug leads to a shorter survival rate in some cancer patients.

The DCGI move came after clinical studies by AstraZeneca Pharma India also supported its withdrawal in specific cases.

“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,” said Dr. Abhishek Shankar, Assistant Professor at Dr BR Ambedkar Institute Rotary Cancer Hospital in AIIMS, Delhi.

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 So its use for this indication was withdrawn by the US FDA on March 26, so this order will certainly restrict the use of a drug which is found to be not efficacious for this indication.”

Olaparib was first approved by DCGI in 2018 for patients with gBRCA mutations (breast cancer) and advanced ovarian cancer, especially those who have undergone multiple chemotherapy treatments.

Dr. Shyam Aggarwal, Chairman of Medical Oncology, Sir Ganga Ram Hospital, said that Olaparib aided in “better ovary cancer control and long-term survival advantage” in patients with advanced ovarian cancer with BRCA mutation or HRD positive who have achieved “a response with chemotherapy in the first and second line of treatment”.

Olaparib’s use in third-line chemotherapy in metastatic ovaries has been withdrawn.

“Olaparib remains available for all other indications at the same price. Olaparib is also approved for BRCA mutant breast cancer in adjuvant and metastatic settings. The drug is also approved in BRCA mutant advanced prostate and pancreas cancer,” he added.