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The Drug Controller General of India (DCGI) has directed the withdrawal of AstraZeneca’s anti-cancer drug, Olaparib tablets, for patients who have undergone three or more prior lines of chemotherapy. This decision affects patients with gBRCA mutation and advanced ovarian or breast cancer due to potential adverse effects. However, Olaparib tablets may still be marketed for other approved indications.
Why is the Drug Being Withdrawn?
On May 16, the DCGI communicated to state and Union territory regulators that AstraZeneca Pharma India Limited requested the withdrawal of Olaparib tablets (100mg and 150mg) for the specified treatment. The decision follows a post hoc subgroup analysis indicating that Olaparib might have a detrimental effect on overall survival compared to chemotherapy in patients who received three or more prior lines of chemotherapy. This analysis was reviewed with oncology experts from the Subject Expert Committee (SEC) during meetings on March 19 and 20, 2024.
The DCGI’s communication instructed state regulators to ensure manufacturers stop marketing Olaparib tablets for these specific cancer treatments. Manufacturers must also submit a revised package insert reflecting this change. Despite this withdrawal, Olaparib tablets can still be sold for other approved uses.
Olaparib tablets were initially approved by the DCGI on August 13, 2018, for the treatment of adult patients with ovarian cancer and certain forms of breast cancer. The recent directive mandates updating the drug’s usage guidelines based on the new clinical evidence provided by AstraZeneca.
The DCGI’s decision to withdraw Olaparib tablets for certain cancer treatments underscores the importance of ongoing clinical evaluations to ensure patient safety. While the drug remains available for other indications, healthcare providers must adhere to the updated guidelines to optimize patient outcomes.
