US FDA Grants Accelerated Approval for Iovance’s Skin Cancer Cell Therapy

Iovance Biotherapeutics announced on Friday that the U.S. health regulator has granted accelerated approval for its cell therapy aimed at treating adult patients with advanced melanoma, marking a significant milestone in the fight against the deadliest form of skin cancer.

The approval from the FDA represents a groundbreaking advancement as it is the first cell therapy targeting a solid tumor to receive regulatory clearance. This revolutionary treatment is intended for use in patients who have undergone previous therapies but whose cancer has metastasized to other parts of the body and cannot be surgically removed.

Lifileucel, branded as Amtagvi, constitutes a tumor-derived immunotherapy comprising the patient’s own white blood cells, specifically tumor-infiltrating lymphocytes (TIL). Priced at $515,000 per patient in the United States, according to interim CEO Frederick Vogt, Amtagvi offers new hope for patients grappling with advanced melanoma.

The accelerated approval of Amtagvi is based on compelling safety and effectiveness data derived from a global study involving 73 patients. However, further confirmatory trials will be required to obtain the FDA’s traditional approval, ensuring continued scrutiny of the therapy’s efficacy and safety profile.

Dr. Jason Bock, co-founder and CEO of Cell Therapy Manufacturing Center, underscored the potential of TIL therapy, emphasizing its applicability to a wide array of solid tumors, which constitute 90% of all cancers.

The study results revealed an encouraging objective response rate of 31.5% among patients treated with Amtagvi at the recommended dosage, signaling its potential to make a meaningful impact in the treatment landscape.

Analysts, such as Michael Yee from brokerage Jefferies, have expressed optimism regarding the market potential of Iovance’s therapy, envisioning it as an attractive acquisition target for larger pharmaceutical companies keen on leveraging this groundbreaking technology.

However, it’s important to note that the therapy’s label includes a boxed warning highlighting potential risks such as treatment-related mortality, severe cytopenia, infections, and cardiopulmonary and renal impairment. Despite these warnings, Vogt remains confident in the therapy’s market viability and anticipates significant revenue generation starting in the second quarter of this year.

In addition to the accelerated approval, Iovance is actively conducting a late-stage trial to further validate the clinical benefits of its revolutionary TIL therapy, underscoring the company’s commitment to advancing the field of cancer treatment and providing hope to patients battling solid tumors.

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