AstraZeneca Pharma shares surged 3% today after the company received a key regulatory nod from India’s Central Drugs Standard Control Organisation (CDSCO). The approval allows AstraZeneca to import and sell its cancer drug Durvalumab (branded as Imfinzi) in India for an additional use.
This new approval covers two dosage forms—120 mg/2.4 ml and 500 mg/10 ml—and expands Imfinzi’s indication to treat adult patients with muscle invasive bladder cancer (MIBC). Specifically, the drug can now be used in combination with gemcitabine and cisplatin as a neoadjuvant (pre-surgery) treatment. After surgery (radical cystectomy), Imfinzi can continue as a standalone adjuvant (post-surgery) therapy.
The expanded label marks a significant milestone for AstraZeneca in India’s oncology market, particularly in bladder cancer treatment. The company can now begin marketing Imfinzi for this new use, subject to any further clearances that may be needed.
Imfinzi is already approved globally for other cancer indications, including lung and biliary tract cancers. This latest CDSCO approval adds another layer to its growing clinical footprint in India.
AstraZeneca Pharma shares opened at ₹9,195.00 and touched a high of ₹9,650.50 during the day. The stock did not fall below its opening price, marking ₹9,195.00 as the low. Over the past year, the stock has seen a 52-week high of ₹10,691.00 and a low of ₹6,220.00.
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