Over a year after rejection, Immunomedics emerges with potential blockbuster approval
A turbulent 16 months for Immunomedics has ended in a potential blockbuster approval, as the FDA granted an accelerated OK for their drug to treat an aggressive form of breast cancer.
The drug, branded as Trodelvy, is approved for metastatic triple negative breast cancer — breast cancers that lack the oncogenes that targeted therapies go after and that have helped make the disease treatable for some patients. The drug, which had breakthrough status and priority review, showed a 33% response and median duration of response of 7.7 months in 108 patients enrolled in their Phase II trial. Peak sales estimates can range as high as around $3 billion.
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