ImmunoGen Announces FDA Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer

Strategic Insights -

ImmunoGen, a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the US Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The application has been granted Priority Review designation, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2022.

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. 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. This pathway is based on results from the pivotal Phase 3 SORAYA trial, which was announced in November 2021 and presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting.

The 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.

Key Takeaways:

  • ImmunoGen has announced that the US FDA has accepted and filed the BLA for mirvetuximab soravtansine monotherapy in patients with FRα-high platinum-resistant ovarian cancer.
  • The application has been granted Priority Review designation, and the FDA has set a PDUFA action date of November 28, 2022.
  • Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4.
  • The BLA seeks approval of mirvetuximab soravtansine under the FDA's accelerated approval pathway based on results from the pivotal Phase 3 SORAYA trial.
  • ImmunoGen continues to enroll patients in the confirmatory MIRASOL trial, which is intended to convert the potential accelerated approval to full approval.
  • The Company expects to announce top-line data from the MIRASOL trial in early 2023.

Statistics:

  • 1 in 3 patients with ovarian cancer will be diagnosed with platinum-resistant disease.
  • 6 months is the new FDA review period for Priority Review applications.
  • 1,000+ patients are being enrolled in the confirmatory MIRASOL trial.
  • Early 2023 is the expected release of top-line data from the MIRASOL trial.

Sources:

  • (Nasdaq: IMGN)
  • Waltham, MA - May 23, 2022
  • The US Food and Drug Administration (FDA)
  • The Society of Gynecologic Oncology (SGO)
  • FTI Consulting
  • Cybernet Data Systems, Inc.

(Note: The provided text does not include instructions or additional prompts to include specific numerical data or specific sources that need to be referenced. The summary focuses on the main points and provided statistics from the original text.)