The U.S. Food and Drug Administration (FDA) has declined to approve Merck and Japan-based Daiichi Sankyo’s lung cancer treatment, patritumab deruxtecan, which belongs to a class of cancer therapies known as “guided missiles”. This decision, communicated through a complete response letter issued late on Wednesday, follows findings from an inspection of a third-party manufacturing facility.
In the letter, the FDA highlighted outstanding questions related to the manufacturing process but did not raise concerns regarding the treatment’s efficacy or safety data submitted by the companies. Merck and Daiichi Sankyo have committed to collaborating closely with the FDA and the third-party manufacturer to address these issues.
Patritumab deruxtecan is an antibody-drug conjugate (ADC), designed to specifically target tumor cells with minimal impact on healthy tissues, akin to a “guided missile”. The therapy was intended for the treatment of non-small cell lung cancer in patients who have not responded to two prior lines of therapy and whose tumors express a particular mutation leading to uncontrolled growth of the EGFR protein.
This setback comes despite Merck and Daiichi Sankyo’s joint efforts under a significant up to $22-billion development and commercialization agreement signed last year, focusing on innovative cancer treatments. Currently, treatments like Johnson & Johnson’s Rybrevant and AstraZeneca’s Tagrisso and Iressa are approved in the U.S. for EGFR-mutated non-small cell lung cancer.
The companies remain committed to advancing patritumab deruxtecan and will continue to work closely with regulatory authorities to address the FDA’s concerns and potentially bring this promising therapy to patients in need.
