AstraZeneca India Halts Marketing of Olaparib for Specific Cancer Treatments Following DCGI Directive

AstraZeneca Pharma India has voluntarily surrendered its marketing authorization for Olaparib tablets (100mg and 150mg) used in treating patients with germline BRCA-mutated (gBRCA) advanced ovarian and breast cancer who have undergone three or more lines of chemotherapy. This decision aligns with a directive from the Drug Controller General of India (DCGI), issued on May 16, 2024, instructing the withdrawal of these specific indications due to potential adverse effects observed in this patient subgroup .

The DCGI’s directive follows a post hoc subgroup analysis indicating a potential detrimental effect on overall survival for patients treated with Olaparib compared to those receiving chemotherapy in the specified subgroup. Consequently, state regulators have been asked to ensure that manufacturers cease marketing Olaparib for these indications and submit revised package inserts reflecting this change .

It’s important to note that Olaparib remains approved for other indications, including its use in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer, as previously authorized by the DCGI .