ImmunoGen announces accelerated approval pathway for mirvetuximab soravtansine
ImmunoGen announced that the U.S. FDA has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine. Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha-high platinum-resistant ovarian cancer who have been previously treated with Avastin. "We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly," said Mark Enyedy, ImmunoGen's President and CEO. "Having aligned with the agency that women with FRalpha-high platinum-resistant ovarian cancer that has progressed after prior treatment with bevacizumab require better therapeutic options, we are pleased to advance mirvetuximab in this patient population with SORAYA, which, if successful, would enable us to submit an application for accelerated approval during the second half of 2021. We anticipate enrolling the first patient in SORAYA next quarter and expect top-line data from the study in mid-2021." ImmunoGen's mirvetuximab program now includes two new trials, SORAYA and MIRASOL, which will enroll concurrently.