Months after exiting its listed Indian subsidiary, Novartis has reinforced its commitment to the country’s innovation medicines market with the launch of India’s first regulatory authority-approved radioligand therapy for advanced prostate cancer, signalling the growing role of India in the Swiss drugmaker’s next-generation treatment strategy.
The launch of Pluvicto comes as multinational pharmaceutical companies increasingly focus on patented medicines, precision oncology and specialty therapies in India, even as domestic drugmakers expand their presence in generics, biosimilars and complex formulations.
Pluvicto (lutetium-177 vipivotide tetraxetan) is designed for eligible patients with Prostate-Specific Membrane Antigen (PSMA)-positive metastatic prostate cancer. The therapy introduces an entirely new treatment approach for prostate cancer patients in India, many of whom are diagnosed only after the disease has spread beyond the prostate.
The launch also highlights the growing maturity of India’s nuclear medicine ecosystem. Novartis is betting on the rapid expansion of India’s nuclear medicine infrastructure. Radioligand therapies require specialised facilities and trained personnel to handle radioactive medicines, limiting their use in many emerging markets. The company estimates India now has more than 250 nuclear medicine centres, suggesting the ecosystem has reached a scale at which advanced targeted radiation therapies can be deployed more widely.
Pluvicto will initially be available through select hospitals and nuclear medicine centres and will be imported from Novartis manufacturing facilities in Spain and Italy.
According to Novartis, India sees around 250,000 prostate cancer cases annually, with more than half diagnosed at advanced stages when treatment options become more limited and outcomes poorer. Prostate cancer is now among the three most common cancers among urban men in the country.
Unlike chemotherapy, which affects both cancerous and healthy cells, radioligand therapy seeks out cancer cells and delivers radiation directly to them. The treatment combines a targeting molecule with the radioactive isotope lutetium-177. The targeting component binds to PSMA, a protein found in large quantities on many prostate cancer cells, allowing radiation to be delivered directly to tumours while limiting exposure to surrounding healthy tissue.
Industry experts view radioligand therapy as one of the most promising frontiers in precision oncology because it combines advances in molecular imaging, nuclear medicine and targeted cancer treatment. Globally, the technology is increasingly being explored across multiple tumour types beyond prostate cancer.
In Phase III studies, Pluvicto demonstrated a significant reduction in the risk of disease progression or death and improved radiographic progression-free survival in eligible patients compared with standard treatment approaches, while also supporting patient-reported quality-of-life outcomes, the company said.
The launch also reflects a broader shift among multinational pharmaceutical companies operating in India. While several global drugmakers have reduced exposure to mature branded-generic portfolios, they are increasingly focusing on innovative medicines, oncology therapies, rare-disease treatments and specialty products, where India offers both a large patient pool and growing clinical capabilities.
Earlier this year, Novartis sold its majority stake in listed Novartis India Ltd in a $159 million transaction. However, the company retained its innovation medicines, research and development, and global operations footprint in the country through its wholly owned subsidiary, Novartis Healthcare Pvt Ltd.
Judith Love has said in recent media interactions that India remains a priority market for the company as it expands its portfolio of innovative medicines and advanced therapies.
Radioligand therapy — explainers
A “guided missile” approach to cancer treatment — finds cancer cells first, then delivers radiation directly to them
Combines precision targeting with radiation therapy in a single treatment.
Unlike chemotherapy, it does not attack the entire body indiscriminately; it is designed to focus on tumour cells.
Unlike conventional radiation, which is delivered from outside the body, radioligand therapy carries radiation directly to the cancer cell
One of the fastest-growing areas in precision oncology globally
Represents a new treatment modality, not just a new drug