AstraZeneca Gets CDSCO Nod to Market Durvalumab for New Cancer Indications in India

AstraZeneca Pharma India Ltd. has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market Durvalumab (Imfinzi) for additional cancer indications. The move expands the drug’s therapeutic reach and reinforces AstraZeneca’s commitment to precision oncology in India.

 

Key highlights:

 

The approval covers Durvalumab solution for infusion in two strengths: 120 mg/2.4 mL and 500 mg/10 mL.

The drug is now permitted for use in combination with chemotherapy as a neoadjuvant treatment, followed by monotherapy post-surgery, for patients with resectable non-small cell lung cancer (NSCLC) without EGFR mutations or ALK rearrangements.

A separate indication allows Durvalumab, in combination with Tremelimumab, for treating unresectable hepatocellular carcinoma (uHCC).

Additionally, Durvalumab can be used with carboplatin and paclitaxel for first-line treatment of advanced or recurrent endometrial cancer, followed by maintenance therapy with Durvalumab and olaparib in mismatch repair proficient (pMMR) cases.

 

Clinical and strategic context:

The approvals are backed by data from the AEGEAN trial and other global studies showing improved survival outcomes in early-stage lung and endometrial cancers.

AstraZeneca aims to accelerate access to innovative therapies in India, aligning with its global strategy to shift cancer treatment to earlier stages.

The company continues to invest in regulatory agility and scientific partnerships to bring novel regimens to Indian patients faster.

 

This regulatory milestone positions AstraZeneca as a key player in India’s evolving oncology landscape, with Durvalumab at the forefront of immunotherapy-led cancer care.

 

Sources: Economic Times, Business Standard, Indian Pharma Post, AstraZeneca India.