Iovance Biotherapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Iovance Biotherapeutics (IOVA).
Over the past two years, Iovance Biotherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Lifileucel. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Lifileucel FDA Regulatory Timeline and Events
Lifileucel is a drug developed by Iovance Biotherapeutics for the following indication: For the Treatment of Advanced Melanoma.
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:
- Lifileucel
- Announced Date:
- August 18, 2025
- Indication:
- For the Treatment of Advanced Melanoma
Announcement
Iovance Biotherapeutics, announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy.
AI Summary
Iovance Biotherapeutics announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), a T cell therapy. It is approved for adult patients with unresectable or metastatic melanoma after at least one prior systemic therapy, including a PD-1 blocking antibody and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
Frederick Vogt, Interim CEO of Iovance, said this marks the company’s first marketing authorization outside the U.S. He noted that Iovance plans to open its first Canadian treatment center soon and is moving ahead with its strategy in other markets.
The conditional approval was based on safety and efficacy data from the global, multicenter C-144-01 Phase 2 trial. In that study, patients previously treated with anti-PD-1 therapy and targeted agents showed measurable tumor responses and lasting benefits. Final confirmation of clinical benefit will depend on results from ongoing trials.
Read Announcement- Drug:
- Lifileucel
- Announced Date:
- June 28, 2024
- Indication:
- For the Treatment of Advanced Melanoma
Announcement
Iovance Biotherapeutics, announced that First of Multiple Planned Global Submissions for Lifileucel in 2024 and 2025
AI Summary
Iovance Biotherapeutics has taken a major step in expanding the global reach of lifileucel, a novel cancer treatment. The company has submitted a marketing authorization application (MAA) to the European Medicines Agency for lifileucel in adult patients with unresectable or metastatic melanoma who have previously received other treatments. This submission marks the first of multiple planned global filings, with additional submissions scheduled for 2024 and 2025. The move is aimed at addressing the unmet need of more than 20,000 patients annually facing advanced melanoma. If approved, lifileucel will become the first and only therapy available in this treatment setting across all European Union member states. Iovance’s strategy underlines their commitment to providing innovative treatment options and underscores the potential global impact lifileucel may have on patient care.
Read Announcement- Drug:
- Lifileucel
- Announced Date:
- June 28, 2024
- Indication:
- For the Treatment of Advanced Melanoma
Announcement
Iovance Biotherapeutics announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. ,
AI Summary
Iovance Biotherapeutics has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a tumor infiltrating lymphocyte (TIL) cell therapy. The therapy is aimed at adult patients with unresectable or metastatic melanoma who have already received treatment with a PD-1 blocking antibody, and for those with the BRAF V600 mutation, it is used alongside a BRAF inhibitor with or without a MEK inhibitor.
If approved, lifileucel will become the first therapy of its kind available across all European Union member states for this specific patient group. This submission is a key step in Iovance’s global expansion efforts, backed by positive clinical data from the C-144-01 trial, and it targets meeting the therapeutic needs of over 20,000 advanced melanoma patients each year.
Read Announcement- Drug:
- Lifileucel
- Announced Date:
- May 23, 2024
- Indication:
- For the Treatment of Advanced Melanoma
Announcement
Iovance Biotherapeutics announced updated clinical data for lifileucel in combination with pembrolizumab in frontline advanced melanoma, as well as translational data, for the upcoming 2024 ASCO Annual Meeting to be held May 31 – June 4, 2024, at McCormick Place in Chicago, IL and online.
AI Summary
Iovance Biotherapeutics announced updated clinical and translational data for lifileucel when combined with pembrolizumab as a frontline treatment for advanced melanoma. The data, coming from Cohort 1A of the IOV-COM-202 trial, will be featured in an oral presentation at the 2024 ASCO Annual Meeting, held from May 31 to June 4, 2024, in Chicago, IL, and online.
The results show a 65% objective response rate with a notable 30% complete response rate in patients who have not previously received immune checkpoint inhibitor therapy. With a median follow-up of 21.7 months, nearly all responses remain ongoing, indicating deep and durable treatment effects. These promising findings support the ongoing Phase 3 TILVANCE-301 trial and underscore lifileucel’s potential as an effective frontline therapy option.
Read Announcement
Iovance Biotherapeutics FDA Events - Frequently Asked Questions
As of now, Iovance Biotherapeutics (IOVA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Iovance Biotherapeutics (IOVA) has reported FDA regulatory activity for Lifileucel.
The most recent FDA-related event for Iovance Biotherapeutics occurred on August 18, 2025, involving Lifileucel. The update was categorized as "Notice of Compliance," with the company reporting: "Iovance Biotherapeutics, announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi® (lifileucel), a tumor-derived autologous T cell immunotherapy."
Currently, Iovance Biotherapeutics has one therapy (Lifileucel) targeting the following condition: For the Treatment of Advanced Melanoma.
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:IOVA) was last updated on 8/22/2025 by MarketBeat.com Staff
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