Merck & Co. and Daiichi Sankyo have withdrawn their application seeking accelerated approval for a small cell lung cancer treatment, saying the data they had submitted to the Food and Drug Administration was insufficient.
The two companies said they decided to withdraw the Biologics License Application for ifinatamab deruxtecan after discussions with the FDA that the data included in the application, including the results of a Phase 2 trial, do not meet the requirements for an accelerated approval.
The companies continue to enroll patients in a Phase 3 trial of the drug. Two other Phase 3 trials evaluating the drug as a treatment for prostate cancer and a form of carcinoma are also under way.
"While we are disappointed that the current dataset are not supportive of an approval at this time, we are continuing to evaluate the role of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer and other types of difficult-to-treat cancer," said Marjorie Green, Merck Research Laboratories head of oncology.
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