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DCGI Mandates Removal of AstraZeneca’s Olaparib for Specific Cancer Treatments

NextEdge Admin

24 May 2024

2 min 48 sec

The Drug Controller General of India (DCGI) has instructed state drug regulators to remove AstraZeneca’s anti-cancer drug Olaparib tablets from the market for specific patient groups. These groups include those who have undergone three or more prior lines of chemotherapy and patients with gBRCA mutation and advanced ovarian cancer and breast cancer. This decision comes due to potential adverse effects highlighted by post hoc subgroup analysis.

AstraZeneca Pharma India Limited voluntarily applied for the withdrawal of indications for Olaparib Tablets 100mg and 150mg for patients with gBRCA mutation and advanced ovarian cancer who have received three or more prior lines of chemotherapy. The decision was supported by clinical evidence showing a potential detrimental effect on overall survival compared to chemotherapy in this subgroup of patients.

In response to this, the DCGI has mandated state regulators to direct manufacturers to cease marketing the drug for the specified indications and to submit updated package inserts. However, it’s important to note that Olaparib remains approved for other indications, as stated by the apex drug regulator.

The DCGI’s communication to regulators on May 16 emphasized the need for manufacturers to withdraw marketing of Olaparib Tablets 100mg and 150mg for the mentioned indications. Manufacturers are also required to submit revised package inserts reflecting these changes. Despite the withdrawal for specific indications, the drug can still be marketed for other approved uses.

Initially approved by the DCGI on August 13, 2018, Olaparib tablets in 100 mg and 150 mg doses were intended for treating adult patients with ovarian cancer and certain forms of breast cancer. This recent directive underscores the importance of ongoing pharmacovigilance and regulatory oversight to ensure patient safety and optimize the use of pharmaceuticals.