Last Updated on November 19, 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.
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.
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.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
Mounjaro Gets Green Light from Expert Committee for Weight Management
Expert Committee Recommends Rationalization of FDCs in India’s Pharma
Trump 2.0 Agenda: A Boon for Indian Pharma Industry?
DGFT Introduces new norm for Clobetasol Propionate: A Boon for Pharma Exporters
17th CPHI & PMEC India 2024 to be held from November 26-28
CDSCO Panel nod granted for Lumateperone Capsule
Drug recall: Dr Reddy’s, FDC recall drugs: A Closer Look
USFDA issued Form 483 with 4 observations to Shilpa Medicare
The Future of Health Supplements: New Stricter Regulations
Delhi High Court grants Injunction in ‘Biochem’ Trademark dispute
Beyond the Pill: DCGI Pushes for Diversified Pharma Education
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: