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US FDA declines to approve Merck-Daiichi’s ‘guided missile’ cancer drug – ET HealthWorld | Pharma

LONDON: The US Food and Drug Administration refused to approve a drug from Merck and Japan-based Daiichi Sankyo. lung cancer This is a fascinating class of cancer treatments, which work like “guided missiles.”

FDA The companies said late Wednesday that they cited findings from a third-party manufacturing plant inspection in their so-called complete response letter.

The letter indicated that the agency had reviewed the companies’ applications and that some questions remain pending, although no issues had been identified with the efficacy or safety data submitted.

The companies said they would work closely with the FDA and the third-party manufacturer to address the feedback.

This treatment is called ‘prophylactic’. patritumab deruxtecanOne of the three is Antibody-drug conjugate (ADC) that were part of Merck’s up to $22 billion joint development and commercialization agreement with Daiichi Sankyo last year.

ADCs are targeted cancer treatments that consist of two key components — a monoclonal antibody that attaches to specific tumor cells and a toxin that kills those cells while not harming healthy cells — in a way thatguided missile,

The companies had sought approval to treat non-small cell lung cancer in patients who have failed two prior therapies and whose tumors have a certain type of mutation that causes uncontrolled growth of the EGFR protein.

Johnson & Johnson’s Ribrevant and AstraZeneca’s Tagrisso and Iressa are currently approved in the US for EGFR-mutated non-small cell lung cancer. (Reporting by Sneha SK and Mariam Sunny in Bengaluru; Editing by Shilpi Mazumdar and Shounak Dasgupta)

  • Published on June 27, 2024 at 04:22 PM IST

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