DCGI: Withdraw Cancer drug ‘Olaparib’ for these treatments

Olaparib remains approved for treating other types of cancers and advanced ovarian cancer cases that fall outside the restricted category.

The Health Master

May 23, 2024

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DCGI CDSCO Regulator Drugs Controller General India — DCGI

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Last Updated on June 4, 2024 by The Health Master

Cancer

Cancer Treatment and You: This article contains vital information for patients with gBRCA-mutated advanced ovarian cancer who have undergone multiple chemotherapy treatments.

The Drug Controller General of India (DCGI), the country’s highest drug regulatory authority, has issued a crucial update regarding the use of Olaparib tablets, an anti-cancer medication manufactured by AstraZeneca.

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Limited Use of Olaparib for Specific Cases

The DCGI has directed state drug regulators to restrict the marketing of Olaparib (100mg and 150mg tablets) for the treatment of advanced ovarian cancer patients with a gBRCA mutation who have received three or more prior chemotherapy regimens.

This decision stems from concerns about potential adverse effects associated with this specific use case.

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Patient Safety First:

Reason for Restriction:

Recent data analysis (post hoc subgroup analysis) revealed a potential negative impact on overall survival for patients taking Olaparib compared to those receiving standard chemotherapy after undergoing three or more prior chemotherapy treatments.

Expert Review:

The DCGI, in collaboration with the Subject Expert Committee (SEC) on Oncology, meticulously reviewed the available evidence during meetings held on March 19th and 20th, 2024.

Clinical Data Provided:

AstraZeneca Pharma India Limited submitted clinical data supporting the withdrawal of this particular use case for Olaparib tablets.

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What This Means for Patients:

Continued Use for Other Indications:

Thankfully, Olaparib remains approved for treating other types of cancers and advanced ovarian cancer cases that fall outside the restricted category.

Consulting Your Doctor:

If you have undergone three or more prior chemotherapy treatments for gBRCA-mutated advanced ovarian cancer, it’s crucial to consult your doctor immediately to discuss alternative treatment options.

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Previous Approval History:

For clarity, it’s important to note that the DCGI initially approved 100mg and 150mg Olaparib tablets on August 13, 2018.

This approval covered the treatment of adult patients with specific forms of breast cancer and ovarian cancer.

Staying Informed:

This update highlights the DCGI’s commitment to patient safety by constantly monitoring the effectiveness and safety of medications.

We recommend discussing any concerns you may have with your doctor and staying informed about developments in your specific cancer treatment plan.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.