New Delhi: India drug regulator has asked state drug regulator To direct the producers of olaparib tablets To stop marketing of 100 mg and 150 mg medicine of cancer For the treatment of patients with “gBRCA mutation” (tumor suppressor gene) and advanced ovarian cancer who have been treated with three or more prior lines Chemotherapy,

This development occurred when AstraZeneca Pharma India The drug regulator was contacted after an analysis “indicated a potentially detrimental effect on overall survival of olaparib compared with the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy,” it said in a letter. were received”. Central Drugs Standard Control Organization To state drug regulators on 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 malignant or suspected “harmful germline BRCA-mutated (gBRCAm) advanced ovarian cancer” who have been treated with 3 or more prior lines of chemo.

Additionally, it was approved for breast cancer in patients with “malignant or suspected malignancy gBRCAM”, “human epidermal growth factor receptor 2 (HERZ)-negative metastatic breast cancer” who have previously received neoadjuvant, adjuvant, or metastatic breast cancer. Was treated with chemotherapy. setting.