FDA Rejects Merck-Daiichi's 'Guided Missile' Cancer Drug

The US FDA has declined to approve Merck and Daiichi's innovative cancer drug, often referred to as a 'guided missile' due to its targeted treatment approach. The decision is based on the need for additional data and further evaluation of the drug's efficacy and safety. This rejection represents a significant setback for the companies, potentially delaying the drug's availability to patients and impacting their development and marketing plans.

Boston Brand Media brings you the latest news - The U.S. Food and Drug Administration has refused to approve the lung cancer treatment developed by Merck (MRK.N) and Japan-based Daiichi Sankyo (4568.T), which is part of a profitable category of cancer therapies known for their precision targeting, similar to "guided missiles." In its complete response letter, the FDA mentioned findings from an inspection of a third-party manufacturing site, the companies announced late on Wednesday. The letter, indicating that the agency has reviewed the application and still has unanswered questions, did not highlight any concerns with the efficacy or safety data provided.

The companies stated they will collaborate with the FDA and the third-party manufacturer to address the feedback. The treatment, named patritumab deruxtecan, is one of three antibody-drug conjugates (ADCs) included in Merck's joint development and commercialization agreement with Daiichi Sankyo, valued at up to $22 billion and signed last year. ADCs are targeted cancer therapies consisting of two primary components — a monoclonal antibody that attaches to specific tumor cells and a toxin that destroys those cells while sparing healthy ones — functioning similarly to a "guided missile."

The companies sought approval for the treatment to address non-small cell lung cancer in patients who have failed two previous lines of therapy and whose tumors express a specific mutation causing uncontrolled growth of the EGFR protein. Currently, Johnson & Johnson's (JNJ.N) Rybrevant and AstraZeneca's (AZN.L) Tagrisso and Iressa are approved in the U.S. for treating EGFR-mutated non-small cell lung cancer.

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Source: Reuters‍