State regulators asked to withdraw marketing of cancer drug Olaparib

Manufacturer AstraZeneca Pharma India says its study shows drug may have detrimental effect

The Central Drugs Standard Control Organisation (CDSCO) has asked regulators in states to make manufacturers of Olaparib tablets to discontinue marketing the anticancer generic drug after clinical studies by AstraZeneca Pharma India supported its withdrawal in specific cases.

Olaparib tablets are used to help maintain the response of certain types of ovarian, fallopian tube, and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely or partially responded to their first or later chemotherapy treatments. It is also used to treat certain forms of breast cancer.

“All state drug regulators are requested to direct all manufacturers of the product Olaparib tablets 100 milligrams (mg) and 150 mg for the treatment of patients with gBRCA mutation (tumour suppressor genes) and advanced ovarian cancer who have been treated with three or more lines of chemotherapy,” said CDSCO in a letter dated May 16.

 

The move to limit the scope of Olaparib comes after AstraZeneca Pharma India, which markets the drug as Lynparza, reached out to the central drug regulator with studies indicating a potential detrimental effect on overall survival for Olaparib compared to the chemotherapy control in the subgroup of patients who had received three or more prior lines of chemotherapy.

“The firm presented clinical evidence for the withdrawal of indications of Olaparib 100 mg and 150 mg tablets for patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more lines of chemotherapy,” said CDSCO.

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

The drug was approved by the central drug regulator in 2018 for indications such as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or peritoneal cancer, and treatment of patients who have been treated with three or more lines of chemotherapy for deleterious (suspected or confirmed) germline BRCA-mutated (gBRCAm) advanced ovarian cancer.

The drug was also approved for the treatment of breast cancer in patients with deleterious (suspected or confirmed) gBRCAm and human epidermal growth factor receptor 2 (HER2)-negative forms of metastatic breast cancer who have previously been treated with chemotherapy in the adjuvant, neoadjuvant, or metastatic setting.