FDA grants regular approval for Trodelvy

The US Food and Drug Administration has granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The FDA approved this application six weeks ahead of the FDA goal date.

The FDA granted the approval to Immunomedics, which had already won accelerated approval for Trodelvy in April 2020, to treat adult patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. The drug generated sales of $49 million in the fourth quarter of 2020.

$4 billion peak sales projected