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Regulator asks state bodies to limit scope of key cancer drug

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India’s drug regulator has asked the state drug regulators to direct manufacturers of Olaparib tablets 100 mg and 150 mg to stop marketing of the cancer drug for the treatment of patients with “gBRCA mutation” (tumour suppressor genes) and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

The development came after AstraZeneca Pharma India approached the drug regulator after an analysis “indicated a potential detrimental effect on overall survival for Olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy”, said a letter by the Central Drugs Standard Control Organisation to state drug regulators dated May 16.

“The drug may continue to be marketed for other approved indications,” the letter said.

Olaparib was initially approved by the regulator in 2018 for indications such as ovarian cancer, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. It was also indicated for the treatment of adult patients with deleterious or suspected “deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer” who have been treated with 3 or more prior lines of chemo.

Simultaneously, it was approved for breast cancer, in patients with “deleterious or suspected deleterious gBRCAm”, “human epidermal growth factor receptor 2 (HERz)-negative metastatic breast cancer” who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.