Discontinue Olaparib Tablets Marketing For Specific Cancers: CDSCO

New Delhi: In a recent notification, the Central Drugs Standard Control Organisation (CDSCO) has directed all manufacturers of the anticancer medication Olaparib Tablets (100mg and 150mg) to discontinue marketing the tablets for the treatment of patients with germline BRCA (gBRCA) mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

This came in line with the clinical evidence presented by the drug major AstraZeneca for the withdrawal of the indication of Olaparib 100mg and 150mg tablets in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Olaparib is a selective and potent inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP1 and PARP2. PARP inhibitors represent a novel class of anti-cancer therapy and they work by taking advantage of a defect in DNA repair in cancer cells with BRCA mutations and inducing cell death. Olaparib is used to treat a number of BRCA-associated tumors, including ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer

The Olaparib Tablets 100mg/150mg were initially approved by this office on 13.08.2018 for the following indications

i. Ovarian cancer

• For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
• For the treatment of adult patients with deleterious or suspected deleterious gBRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

ii. Breast cancer

• In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2(HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.

AstraZeneca Pharma India Limited submitted an application to the directorate for the withdrawal of indications for Olaparib Tablets 100mg and 150mg in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy based on post hoc subgroup analysis indicating a potential detrimental effect on overall survival (OS)for Olaparib compared to the chemotherapy control arm in the subgroup of patients who had received three or more prior lines of chemotherapy.

In continuation, the matter was reviewed in consultation with Subject Expert Committee (SEC) (Oncology) experts in the 06/24 meeting held on 19.03.2024 and 20.03.2024 at CDSCO (HQ), New Delhi where after detailed deliberation, the committee agreed to withdrawal of the same indication.

The firm presented the clinical evidence for the withdrawal of the indication of Olaparib 100mg and 150mg tablets in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy and accordingly, the firm was directed to withdraw the said indication and revise the package insert.

In view of the above circumstances, the Drugs Controller General of India wrote to all State/UTs Drugs Controller :

"You are requested to direct all the manufacturers of the said drug under your jurisdiction to withdraw marketing of the product Olaparib Tablets 100mg and 150mg approved by your office for the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy indication and submit the revised package insert. The drug may continue to be marketed for other approved indications."