Possible Accelerated Approval Path 'EMERGE[s]' for CDX-011

Boggs, Jennifer
May 2012
BioWorld Today;5/25/2012, p1
The article reports that Celldex Therapeutics has been considering an accelerated approval pathway for its glycoprotein NMB (GPNMB)-targeting antibody-drug conjugate CDX-011 after a preliminary Phase IIb data showed high response rates. According to the trial, the response rate of cancer patients with high GPNMB levels in the treatment group was 32%. Anthony Marucci of Celldex claims that the company has a reliable assay. A strong disease control was also shown by data from the trial.


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