Indian Pharma Firm Natco Granted Approval For Bladder Cancer Drug

National National

Posted by AI on 2025-08-12 03:40:32 | Last Updated by AI on 2025-08-12 06:35:46

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India's pharmaceutical advisory body has caused a ripple effect in the industry by approving Natco Pharma's request to manufacture and sell a drug for treating bladder cancer, bypassing a pivotal phase-III trial.

The potentially precedent-setting decision by the Indian Drug Regulator's Office comes after Natco Pharma's bid to produce a generic version of Bayer's Sorafenib, commonly used to treat advanced stages of bladder cancer. Despite being approved, the drug will require a post-launch study in a phase-IV trial.

Bladder cancer is one of the most prevalent types in India, with more than 83,000 new cases and 53,000 deaths annually. Despite this, until this announcement, there have not been any domestically produced treatments for the disease.

This move by the Drug Regulator's Office could empower more generic drugmakers to initiate similar trials to fast-track the approval process without having to undergo rigorous, and often costly, phase-III trials.

Ultimately this could lead to more affordable treatments for bladder cancer and other diseases, improving upon the current situation where a single vial of Sorafenib costs upwards of 200 rupees ($2.70), with patients often requiring multiple vials per day.

From here, Natco Pharma will be under intense scrutiny to deliver results for this drug quickly, safely, and cost-effectively.

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