ImmunoGen higher on FDA decision

ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine

ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine , Stockwinners
ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine

ImmunoGen (IMGN) announced that the U.S. FDA has granted Fast Track designation for its lead program, mirvetuximab soravtansine.

The designation is for the treatment of patients with medium to high folate receptor alpha-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy.

Mirvetuximab soravtansine is being evaluated in the FORWARD I Phase 3 trial.

The trial is designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy.

Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of FRalpha who have been treated with up to three prior regimens.

The primary endpoint of this study is Progression Free Survival, which is being assessed in the entire study population and in the subset of patients with high FRalpha expression.

Enrollment of FORWARD I was completed ahead of schedule in April 2018 and ImmunoGen expects to report top-line results from the FORWARD I trial in the first half of 2019. ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which is being conducted in North America and Europe.

This trial is intended to support full marketing approval of mirvetuximab for patients with platinum-resistant ovarian cancer.

Mirvetuximab soravtansine is also being assessed in multiple combinations in the FORWARD II trial.

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin, or Keytruda in patients with FRalpha-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

IMGN closed at $10.01, it last traded at $10.65.


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