Approval of Anti Cancer drug Nivolumab for new Indication

This approval positions Opdivo (Nivolumab) as a first-line treatment option, providing patients with earlier access to a potentially life-saving therapy.

The Health Master

November 19, 2024

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Expert Committee Meeting — Picture: Pixabay

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Last Updated on November 29, 2024 by The Health Master

Nivolumab

Bristol-Myers Squibb’s anti cancer drug, Opdivo (Nivolumab), has received a significant boost in India.

The Subject Expert Committee (SEC) has recommended approval an additional indication for the drug, expanding its therapeutic potential.

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What’s the New Indication?

Opdivo (Nivolumab), in combination with cisplatin and gemcitabine, has been approved for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

This is a major development, as it offers a new treatment option for patients with this aggressive form of bladder cancer.

Why is this Approval Significant?

First-Line Treatment: This approval positions Opdivo (Nivolumab) as a first-line treatment option, providing patients with earlier access to a potentially life-saving therapy.
Global Standard of Care: The combination therapy has already been approved in major markets like the US, Europe, and Canada, establishing it as a global standard of care.
Clinical Trial Waiver: The committee also recommended a waiver for local Phase III clinical trials, accelerating the drug’s availability to Indian patients.

How Does Opdivo (Nivolumab) Work?

Opdivo (Nivolumab) is an immune checkpoint inhibitor that works by boosting the body’s natural defenses to fight cancer cells.

By blocking specific proteins, Opdivo (Nivolumab) helps the immune system recognize and attack cancer cells more effectively.

What are the Potential Benefits of Opdivo (Nivolumab)?

Clinical trials have shown that Opdivo (Nivolumab), in combination with chemotherapy, can significantly improve overall survival and progression-free survival in patients with advanced UC.

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