24 May 2022 - - The US Food and Drug Administration has accepted and filed the Biologics License Application for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha -high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments, US-based biotechnology company ImmunoGen, Inc. (NASDAQ: IMGN) said.

The application has been granted Priority Review designation and FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.

Priority Review designation is granted to applications for therapies that may offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications and shortens the FDA review period to six months following acceptance.

The BLA seeks approval of mirvetuximab soravtansine under the FDA's accelerated approval pathway, which was instituted to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint and is based on results from the pivotal Phase 3 SORAYA trial.

Top-line data from SORAYA were announced in November 2021 and full data from the study were presented at the Society of Gynecologic Oncology 2022 annual meeting.

ImmunoGen said it continues to enroll patients in the confirmatory MIRASOL trial, which is intended to convert the potential accelerated approval to full approval, and expects to announce top-line data from this study in early 2023.

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days.