India’s drug regulator has granted a significant new approval for the cancer drug Imfinzi, potentially expanding treatment options for certain cancer patients in the country. The Central Drugs Standard Control Organisation (CDSCO) has authorised the import, sale and distribution of durvalumab solution for infusion — marketed as Imfinzi — for use in first-line treatment of select advanced cancers in adults, marking a key regulatory milestone for the immunotherapy agent.

The approval allows Imfinzi, in combination with standard chemotherapy agents carboplatin and paclitaxel, to be used as an initial systemic therapy for adults with primary advanced or recurrent endometrial cancer who are eligible for such treatment. Following combination therapy, Imfinzi can then be continued as a maintenance monotherapy for patients with endometrial cancer that is mismatch repair deficient (dMMR), a subtype of the disease characterised by specific genetic features that can make tumours more responsive to immunotherapy.

This expanded indication positions Imfinzi as an option earlier in the treatment course for eligible patients, rather than as a later-line therapy. Endometrial cancer, a malignancy of the uterine lining, can be challenging to treat in advanced or recurrent stages, and immunotherapy combinations have increasingly been studied to improve outcomes. The new CDSCO nod follows a regulatory filing from AstraZeneca Pharma India Ltd, which highlighted the clinical rationale behind combining durvalumab with chemotherapy in first-line settings.

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AstraZeneca’s announcement has also had a visible market impact, with reports of a modest rise in the company’s share price after the approval was disclosed. Investors interpreted the news as an indication of the drug’s broader commercial potential in India’s growing oncology market.

While the CDSCO clearance paves the way for Imfinzi’s expanded use, the company will still need to complete any related statutory requirements before full commercial rollout. Clinicians and healthcare systems will be watching closely as implementation progresses, given the importance of first-line treatment options in improving survival and quality of life for cancer patients.

Globally, Imfinzi has been studied across a range of cancer types and approved in various settings, including lung and other tumour types in several regions. The Indian approval reflects a broader trend of bringing immuno-oncology therapies into earlier lines of treatment, offering new hope for patients and oncologists seeking more effective interventions.

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