DCGI orders withdrawal of Olaparib for select cancer patients over safety concerns

New Delhi: The Drug Controller General of India (DCGI), Rajeev Raghuvanshi, has directed state authorities to withdraw AstraZeneca’s Olaparib Tablets, 100mg and 150mg, due to potential adverse effects on patients who have received three or more prior lines of chemotherapy. 

The decision will impact the treatment of ovarian and breast cancer patients with specific genetic mutations.

Withdrawing drug

AstraZeneca, which received approval for Olaparib in 2018, has submitted an application to withdraw the drug for patients with gBRCA mutations (breast cancer) and advanced ovarian cancer, especially those who have undergone multiple chemotherapy treatments. 

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According to the DCGI, the move follows a post-hoc subgroup analysis that indicated potential adverse effects on patients treated with Olaparib.

“Based on the post hoc subgroup analysis indicating a potential detrimental effect on overall survival (OS) for Olaprarib compared to the chemotherapy control arm in subgroup of patients, who have received three or more prior lines of chemotherapy, the firm has now been directed to withdraw the said indication and revise the package insert" the DCGI said in a letter, which was reviewed by Mint. 

“In view of above circumstances, you (state drug regulators) are requested to direct all the manufacturers of the said drug under your judications to withdraw marketing of the product and submit the revised package insert,” he said.

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Raghuvanshi said state regulators must ensure implementation of the order until further notice. However, despite this withdrawal, Olaparib will continue to be marketed for other approved indications, he added.

Olaparib, marketed under the brand name Lynparza, was valued at $10.3 billion in 2023, and is projected to reach $19.49 billion by 2030, with a compound annual growth rate (CAGR) of 10.1% between 2024 and 2030.

“We wish to inform you that the company has now received permission for voluntary withdrawal of Olaparib (Lynparza) 100mg and 150 mg tablets from the CDSCO (Central Drugs Standard Control Organisation),” AstraZeneca said in a filing with the BSE.

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Queries sent to a health ministry spokesperson remained unanswered till press time.

Dr Abhishek Shankar, oncologist at AIIMS, Delhi, said, “This decision of withdrawing the use of Olaparib in cancer patients is the right move to maintain the evidence-based treatment and justified as patients who were taking Olaparib potentially had a shorter overall survival (OS) than patients not on Olaparib, particularly in the subgroup analysis of patients who had received three or more lines of chemotherapy. So, this order will certainly restrict the use of a drug which is found to be not efficacious for this indication.”

Dr Shyam Aggarwal, chairman of oncology department at Sir Gangaram hospital echoed Dr Shankar. He said Olaparib shows good results when used early in patients rather than using it later in patients who have had two to three rounds of chemotherapy earlier.