23 May 2024 • In a significant development, the Drug Controller General of India (DCGI) has mandated the withdrawal of Olaparib tablets (100 & 150mg dosages) for specific cancer treatments.

The directive, issued to drug regulators across all states and Union territories, specifically targets patients with gBRCA mutation and advanced ovarian and breast cancer who have undergone three or more prior lines of chemotherapy.

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. This decision comes after a post hoc subgroup analysis indicated a potential detrimental effect on overall survival when comparing Olaparib to the chemotherapy control arm in this specific patient subgroup.

While the withdrawal is confined to the specified patient cohort, Olaparib will remain available for other approved indications, as affirmed by the apex drug regulator.

Source: OneIndia News | Read full story