Novartis India has 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.
Pluvicto is designed to target prostate cancer cells while minimising exposure to healthy tissues. The therapy introduces a treatment approach for metastatic prostate cancer.
The company stated that prostate cancer is among the top three cancers affecting urban men in India, with nearly 250,000 cases every year. Approximately 50 per cent of diagnosed patients present at a metastatic stage, where treatment becomes more complex due to 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.”
Novartis stated that India’s nuclear medicine ecosystem includes more than 250 nuclear medicine centres across the country. The company 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.
Pluvicto (lutetium (177Lu) vipivotide tetraxetan) is an intravenous radioligand therapy that combines a targeting compound with a therapeutic radionuclide.
Following 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. The therapy delivers targeted radiation to cancer cells while minimising the impact on healthy tissue.
According to Novartis, Pluvicto is the only regulatory authority approved finished formulation for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The therapy is imported from Spain and Italy from GMP facilities. In the Phase III clinical study, Pluvicto demonstrated a reduction in the risk of disease progression or death and an improvement in radiographic progression-free survival compared to standard approaches in eligible patients, along with a consistent and manageable safety profile. The study also reported improvements in patient-reported quality-of-life measures in defined treatment settings.