Iovance Biotherapeutics (IOVA) FDA Approvals

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.

Data - February 5,2026

• Drug: Lifileucel
• Announced Date: February 5, 2026
• Indication: For the Treatment of Advanced Melanoma

Iovance Biotherapeutics, announced data demonstrating a best-in-class profile for commercial Amtagvi® (lifileucel) with unprecedented response rates in a real-world clinical, retrospective study in patients with advanced (unresectable or metastatic) melanoma.

Iovance Biotherapeutics reported real-world, retrospective clinical data showing commercial Amtagvi® (lifileucel) has a best-in-class profile with unprecedented response rates in patients with advanced, unresectable or metastatic melanoma. These real-world results were highlighted in an oral presentation at the 2026 Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT®) and the Center for International Blood and Marrow Transplant Research (CIBMTR®) in Salt Lake City, Utah.

Daniel Kirby, Iovance’s Chief Commercial Officer, said the data show impressive response rates plus unprecedented five-year durability and survival. He noted patients treated earlier had better outcomes. The findings suggest Amtagvi may offer durable benefit in routine clinical practice for people whose melanoma has progressed after prior therapies. Further study and follow-up will clarify how these real-world results fit into treatment decisions.

Notice of Compliance - August 18,2025

• Drug: Lifileucel
• Announced Date: August 18, 2025
• Indication: For the Treatment of Advanced Melanoma

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.

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.

Regulatory Update - June 28,2024

EMA

• Drug: Lifileucel
• Announced Date: June 28, 2024
• Indication: For the Treatment of Advanced Melanoma

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. ,

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.

Provided Update - June 28,2024

• Drug: Lifileucel
• Announced Date: June 28, 2024
• Indication: For the Treatment of Advanced Melanoma

Iovance Biotherapeutics, announced that First of Multiple Planned Global Submissions for Lifileucel in 2024 and 2025

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.