Breaking through barriers and making waves in the healthcare industry, Iovance Biotherapeutics (NASDAQ:IOVA) has been granted the prestigious FDA accelerated approval for its groundbreaking T-cell immunotherapy lifileucel, also known as Amtagvi. This significant milestone marks a pivotal moment in the treatment of advanced melanoma.

According to the biotech company’s official statement, Amtagvi has etched its name in history as the first and only one-time, individualized T-cell therapy to secure FDA approval for the treatment of a solid tumor cancer, delivering a beacon of hope to patients battling this relentless disease.

The company announced that the product will be meticulously manufactured at the Iovance Cell Therapy Center in Philadelphia, underscoring the company’s commitment to top-notch standards and quality assurance in the production of this life-changing therapy.

Earlier in September, Iovance had revealed that the FDA was extending the goal date for its decision to Feb. 24 due to resource constraints, causing a ripple of anticipation in the market. The news of the FDA accelerated approval has propelled shares of Iovance, causing the stock to be halted at 2:35 p.m. ET on Friday as the market absorbed the monumental announcement.