Oncologists on 23 May supported the Drug Controller General of India's (DCGI) mandate to state authorities to withdraw AstraZeneca’s anticancer generic drug Olaparib over safety concerns.

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

In a letter dated May 16, a Doctor from DCGI wrote to state drug regulators to discontinue marketing AstraZeneca’s Olaparib tablets (100mg and 150mg) sold as Lynparza, due to potential adverse effects on some patients who have received three or more prior lines of chemotherapy. According to health experts, the drug led to a shorter survival rate in some cancer patients.

The DCGI move comes 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, Department of Radiation Oncology, Delhi.

The oncologist noted that “patients who were taking Olaparib potentially had 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“So its use for this indication was withdrawn by the US FDA on March 26, so this order will certainly restrict the use of a drug which is found to be not efficacious for this indication.”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, 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”.

Now Olaparib’s use in third-line chemotherapy in metastatic ovary has been withdrawn.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