The Drug Controller General of India (DCGI) has instructed drug regulators across all states and Union territories to stop the use of AstraZeneca’s anti-cancer drug Olaparib for specific treatments. This decision affects patients who have already undergone three or more lines of chemotherapy.
State regulators have been directed to ensure that manufacturers cease marketing Olaparib for patients with gBRCA mutation who have advanced ovarian or breast cancer. This move is due to potential adverse effects. Additionally, manufacturers must submit a revised package insert that reflects this change.
However, the drug can still be sold and used for other approved medical conditions.
The DCGI communicated these instructions on May 16, stating that AstraZeneca Pharma India Limited had requested to withdraw these specific indications for Olaparib Tablets in doses of 100mg and 150mg. This request follows findings from a detailed analysis that suggested Olaparib might negatively impact overall survival for patients who have had three or more previous chemotherapy treatments.
The decision was made after consultations with oncology experts from the Subject Expert Committee (SEC). They reviewed the evidence in meetings held on March 19 and 20, 2024, at the Central Drugs Standard Control Organization (CDSCO).
AstraZeneca provided clinical data to support the removal of these indications for Olaparib. Following this review, the DCGI advised state regulators to ensure that all manufacturers stop marketing Olaparib for the affected patient group. They must also update the package insert with the new information.
The DCGI’s communication mentioned that Olaparib Tablets in the 100mg and 150mg dosages were initially approved on August 13, 2018. The approval was for treating adult patients with ovarian cancer and certain types of breast cancer.
To summarize:
– The DCGI has ordered the withdrawal of Olaparib for patients with gBRCA mutation who have advanced ovarian or breast cancer and have had three or more lines of chemotherapy.
– This decision is due to potential negative effects on overall survival in these patients.
– Olaparib can still be marketed for other approved treatments.
– Manufacturers must update the drug’s package insert to reflect these changes.
This decision aims to ensure patient safety based on the latest clinical evidence, demonstrating the regulator’s commitment to adapting treatment guidelines as new information becomes available.
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