DCGI Orders Withdrawal of Cancer Drug Olaparib for Certain Treatments
In a significant move aimed at patient safety and treatment efficacy, the Drug Controller General of India (DCGI) has mandated the withdrawal of AstraZeneca's anti-cancer drug, Olaparib tablets, for a specific patient subgroup. This decision affects patients with advanced ovarian cancer who have a germline BRCA mutation (gBRCA) and have already undergone three or more lines of chemotherapy. The directive, issued on May 16, 2024, calls on state and Union Territory regulators to ensure compliance with this order. Why the Withdrawal? The impetus for this withdrawal stems from a post hoc subgroup analysis, which indicated a potential detrimental effect on overall survival for patients receiving Olaparib in the specified conditions compared to those receiving chemotherapy. These findings were reviewed in consultation with the Subject Expert Committee (Oncology) during meetings held on March 19 and 20, 2024, by the Central Drugs Standard Control Organization (CDSCO). AstraZe...
