Novartis Deepens Commitment to India with Launch of Pluvicto®, the Country’s First Regulatory Authority Approved Radioligand Therapy for Advanced Prostate Cancer

June 2026: Prostate cancer is a growing health challenge in India, with over 250,000 cases1 annually and more than half detected at advanced stages, underscoring the urgent need for earlier diagnosis and improved access to advanced treatment options.

Radioligand therapy introduces a more targeted treatment approach with the potential to delay disease progression, support overall survival in defined settings, and improve quality of life for patients.

Pluvicto is the country’s first regulatory authority approved radioligand therapy, marking a significant step forward in precision oncology for advanced prostate cancer.

The launch of Pluvicto reflects Novartis’ continued commitment to bringing innovative, regulatory-approved therapies that are manufactured in Good Manufacturing Practice (GMP)-compliant facilities, reflecting high standards of quality and safety.

In a major advancement for cancer care in India, Novartis India announced the launch of Pluvicto(lutetium (177Lu) vipivotide tetraxetan), the country’s first regulatory authority approved radioligand therapy for eligible patients with Prostate-Specific Membrane Antigen (PSMA)-positive prostate cancer. Designed to precisely target prostate cancer cells while minimizing exposure to healthy tissues, Pluvicto introduces a new treatment approach for metastatic prostate cancer, a disease that continues to place a significant physical and emotional burden on patients and families across India.

The launch comes at a time when prostate cancer is emerging as one of India’s fastest-growing cancer burdens among men. Prostate cancer is now among the top three cancers affecting urban men in India, with nearly 250,000 cases1 every year. Approximately 50% of diagnosed patients3 present at a metastatic stage, where treatment becomes significantly more complex due to poorer prognosis, treatment-related side effects, and challenges in treatment sequencing.

Judith Love, Region Head Asia Pacific Middle East Africa, Novartis, said, “India is a priority market for Novartis, with growing momentum in precision oncology and advanced cancer care. The introduction of Pluvicto marks a meaningful step forward – bringing globally approved innovation closer to patients who need more targeted treatment options. What makes this launch especially impactful is not just the science, but the opportunity to expand access through India’s growing nuclear medicine infrastructure. We remain committed to enabling access to next-generation treatments, and I’m excited about the difference Pluvicto can make for patients in India.”

Amitabh Dube, Country President and Managing Director, Novartis India, said, “In India, a large proportion of prostate cancer patients continue to be diagnosed only after the disease has progressed to a metastatic stage, limiting treatment options and impacting quality of life. With the launch of Pluvicto, we are bringing a globally recognized radioligand therapy platform to India at a time when the need for precision oncology solutions is increasing rapidly. Beyond the therapy itself, our focus is on building long-term partnerships with hospitals and healthcare stakeholders to help strengthen access pathways, multidisciplinary collaboration, and readiness for the future of nuclear medicine in India.”

“India’s nuclear medicine ecosystem has expanded significantly over the past decade and today includes more than 250 nuclear medicine3 centres across the country. Novartis plans to collaborate with healthcare institutions, oncologists, nuclear medicine specialists, and hospital partners to support treatment readiness and multidisciplinary care pathways for eligible patients.”

“Pluvicto will be made available through select hospitals and nuclear medicine centres across India as part of Novartis’ partnership-led approach for bringing radioligand therapies to India. The company is also working with healthcare stakeholders to strengthen awareness, and infrastructure preparedness for precision oncology care.”

About Pluvicto

Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is an intravenous radioligand therapy that combines a targeting compound with a therapeutic radionuclide.

After administration into the bloodstream, Pluvicto binds to Prostate Specific Membrane Antigen (PSMA)-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death. In short, it works by delivering targeted radiation to cancer cells, helping to improve precision while minimizing the impact on healthy tissue.

Pluvicto is the only regulatory authority approved finished formulation for PSMA +metastatic castration resistant prostate cancer (mCRPC) and is imported from Spain and Italy from GMP facilities, ensuring the highest standards of quality and safety. In the Phase III clinical study, Pluvicto demonstrated a significant reduction in the risk of disease progression or death and a meaningful improvement in radiographic progression-free survival compared to standard approaches in eligible patients, along with a consistent and manageable safety profile. These outcomes are complemented by improvements in patient-reported quality-of-life4 measures in defined treatment settings, reflecting the potential of radioligand therapy not only to extend outcomes but also to support a better treatment experience for patients.

About Prostate Cancer

Prostate cancer is a significant and growing health challenge in India, particularly among urban male populations, with an estimated over 250,000 cases1 each year. A substantial proportion of these patients present with advanced or metastatic disease, with studies indicating that over 50% of prostate cancer cases in India are detected at advanced stages, when treatment becomes more complex and outcomes are often poorer. Limited awareness, delayed diagnosis, and variability in access to advanced diagnostics and treatment pathways continue to impact patient outcomes. As the burden is expected to rise with an aging population and improved detection, there is a need for timely access to effective therapies alongside strengthening healthcare system readiness to support comprehensive cancer care.

About Novartis in India

Novartis has had a significant footprint in India since 1947 and is present through its wholly owned subsidiary, Novartis Healthcare Private Limited. India is among a handful of countries with a broad Novartis footprint spanning innovative medicines, drug development, biomedical research, and global operations. Novartis in India employs more than 9,000 associates committed to improving and extending people’s lives through science and innovation. Novartis India has consistently been recognized as a Top Employer and certified as a Great Place To Work®.

Novartis’ commercial operations in India are focused on bringing innovative medicines to patients in priority disease areas including cardiovascular, oncology, immunology and spinal muscular atrophy. Through science-led innovation and long-term commitment, Novartis continues to strengthen its role as a trusted partner in India’s healthcare ecosystem.

For more information about Novartis in India, explore https://www.novartis.com/in-en/.

Author: ADmiNIstRAtoR