FDA Events for ImmunoGen (IMGN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by ImmunoGen (IMGN).
Over the past two years, ImmunoGen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ELAHERE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ELAHERE (mirvetuximab soravtansine-gynx) - FDA Regulatory Timeline and Events
ELAHERE (mirvetuximab soravtansine-gynx) is a drug developed by ImmunoGen for the following indication: ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ELAHERE (mirvetuximab soravtansine-gynx)
- Announced Date:
- June 6, 2024
- Indication:
- ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells
Announcement
AbbVie announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC).
AI Summary
AbbVie announced positive topline results from its Phase 2 PICCOLO trial, which studied the investigational mirvetuximab soravtansine (ELAHERE®) in heavily pre-treated patients with folate receptor-alpha positive, platinum-sensitive ovarian cancer. The trial met its primary endpoint with an objective response rate (ORR) of 51.9%, suggesting a strong treatment effect in these patients who have limited options. Additionally, the study reported a median duration of response of 8.25 months, indicating that the benefits of the treatment may last for a significant period. The safety profile observed was consistent with previous studies, with no new safety concerns, which supports the potential for mirvetuximab soravtansine as an effective option for women facing multiple lines of therapy. Full data from this trial will be shared at an upcoming medical meeting, adding further insight into its clinical promise.
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ImmunoGen FDA Events - Frequently Asked Questions
As of now, ImmunoGen (IMGN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, ImmunoGen (IMGN) has reported FDA regulatory activity for ELAHERE (mirvetuximab soravtansine-gynx).
The most recent FDA-related event for ImmunoGen occurred on June 6, 2024, involving ELAHERE (mirvetuximab soravtansine-gynx). The update was categorized as "Top-line results," with the company reporting: "AbbVie announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC)."
Currently, ImmunoGen has one therapy (ELAHERE (mirvetuximab soravtansine-gynx)) targeting the following condition: ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:IMGN) was last updated on 7/10/2025 by MarketBeat.com Staff
