Olaparib's Use Restricted for Advanced Ovarian Cancer Treatment
The Central Drugs Standard Control Organisation (CDSCO) has restricted the use of Olaparib tablets for the treatment of advanced ovarian cancer in patients who have received three or more lines of chemotherapy. This decision was made based on studies submitted by AstraZeneca Pharma India, which markets the drug as Lynparza, indicating a potential negative impact on overall survival for Olaparib compared to chemotherapy in this specific patient group.
The CDSCO has requested all state drug regulators to direct manufacturers of Olaparib tablets to limit their marketing of the 100mg and 150mg dosages for the aforementioned indication. However, Olaparib can still be marketed for other approved uses, such as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or peritoneal cancer, and treatment of patients with deleterious (suspected or confirmed) germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more lines of chemotherapy.
Olaparib was initially approved by the CDSCO in 2018 for various indications, including the treatment of advanced ovarian cancer and breast cancer in patients with specific genetic mutations. This recent restriction applies only to the use of Olaparib for advanced ovarian cancer in patients who have received extensive prior chemotherapy treatment.