Novartis Introduces Pluvicto, India's First Approved Radioligand Therapy

NVS (Novartis) has launched Pluvicto in India, making it the country's first regulatory authority-approved radioligand therapy for advanced prostate cancer. The treatment, generically known as lutetium-177 vipivotide tetraxetan, is indicated for eligible patients with PSMA-positive metastatic castration-resistant prostate cancer whose disease has progressed despite standard therapies. Initially, the therapy will be available through selected hospitals and nuclear medicine centers and will be imported from Novartis manufacturing facilities in Spain and Italy.

Pluvicto works by combining a PSMA-targeting molecule with the radioactive isotope Lutetium-177, which allows it to locate prostate cancer cells with high specificity and deliver targeted radiation. Phase III clinical data have demonstrated that Pluvicto significantly reduces the risk of disease progression or death compared with standard-of-care alternatives for eligible patients. The India launch follows earlier approvals in the United States and Europe, and it places India among the markets with regulatory access to this generation of precision oncology therapies.

For NVS, India's approval is a revenue-diversification opportunity in a large and growing oncology market, though near-term commercial scale will be constrained by the import-reliance, the specialized nuclear medicine infrastructure required for administration, and affordability dynamics in the Indian healthcare system. The competitive backdrop is also relevant: AstraZeneca received U.S. approval for Truqap in combination therapy for PTEN-deficient metastatic prostate cancer, and the two treatments address overlapping patient populations, meaning Novartis will need to differentiate Pluvicto on clinical outcomes and institutional access to sustain its position in the precision oncology space globally.