In a landmark achievement, Calyx, a prominent provider of Medical Imaging services, alongside IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management), has played a pivotal role in supporting the FDA’s groundbreaking approval of Iovance Biotherapeutic’s AMTAGVI™ (lifileucel) for the treatment of adult patients with unresectable or metastatic melanoma who have relapsed on other front-line therapy. This approval marks a significant milestone in the field of oncology as AMTAGVI becomes the first cell therapy approved to combat solid tumors, which constitute 90% of all cancers.

Calyx Medical Imaging’s involvement in the accelerated Phase II clinical trial was instrumental in achieving this historic milestone. With expertise in designing and implementing imaging components, Calyx facilitated the seamless capture of patient images across 60 investigative sites through various modalities including CT, MRI, PET, and skin photography, all in strict adherence to the trial protocol. Recognizing the unique challenges posed by image review in cell therapy, Calyx’s oncology imaging experts devised a meticulous image review methodology, ensuring uniform and consistent evaluation by Calyx’s independent readers.

David Herron, CEO of Calyx Medical Imaging, underscored the significance of this achievement, stating, “The work that Iovance is doing is extremely important, not only to melanoma patients and their loved ones but also to the broader oncology research community. We are honored to have played a role in this important development program and look forward to continuing our collaboration with the Iovance team.”

This groundbreaking approval not only signifies a major advancement in the treatment landscape for melanoma patients but also reflects the collective efforts of industry leaders like Calyx and Iovance in driving innovation and pushing the boundaries of medical science. With Calyx’s unwavering commitment to excellence in medical imaging services and its pivotal role in supporting transformative clinical trials, the company continues to reinforce its position as a trailblazer in the field of healthcare technology.

As the healthcare industry witnesses unprecedented breakthroughs, collaborations between innovative companies like Calyx and Iovance underscore the collective determination to revolutionize patient care and bring hope to those battling life-threatening diseases. The approval of AMTAGVI represents a significant step forward in the fight against melanoma and paves the way for future advancements in cell therapy and oncology research.