Sheba Medical Center Bridges Europe's TIL Therapy Gap for Advanced Melanoma Patients
核心洞察
Sheba Medical Center has delivered TIL therapy for over 15 years, treating more than 200 melanoma (搜索) patients through its established clinical program.
The withdrawal of a commercial manufacturer's EMA application has left European patients with limited access to TIL therapy outside of highly selective clinical trials.
Sheba's Advanced Biotherapy Center enables on-site GMP-compliant manufacturing, with its CAR-T program achieving a 98.8% manufacturing success rate and an 11-day vein-to-vein time.
For patients with advanced melanoma (搜索) in Germany and Austria—and across Europe more broadly—access to tumor-infiltrating lymphocyte (TIL) therapy (搜索) has become increasingly constrained. The withdrawal of a commercial manufacturer's European Medicines Agency (EMA) application disrupted the anticipated rollout of TIL therapy across the continent, leaving this potentially life-saving treatment largely confined to highly selective clinical trials. At Sheba Medical Center in Israel, however, TIL therapy is not an emerging concept: it has been an established clinical program for more than 15 years, during which time the center has treated more than 200 melanoma patients.
A Critical Gap in European Melanoma (搜索) Care
For patients whose advanced melanoma (搜索) has progressed despite standard therapies, the lack of commercially available TIL therapy in Europe represents a significant unmet medical need. While clinical trials provide some access, the restrictive nature of these studies means many patients who could potentially benefit are left without viable options. Sheba Medical Center, ranked among the world's Top 10 hospitals by Newsweek for eight consecutive years and placed #7 globally in 2026, has positioned itself as a destination for patients seeking advanced cellular therapies that remain difficult to access in their home countries.
The Integrated Manufacturing Advantage
At the heart of Sheba's TIL program is the Advanced Biotherapy Center (ABC), Israel's largest Good Manufacturing Practice (GMP) compliant advanced biotherapy facility. Unlike many institutions that depend on external or centralized manufacturing partners, Sheba coordinates the entire treatment pathway—tumor collection, cell expansion, treatment planning, infusion, and follow-up—within a single institution. This integrated model brings together a multidisciplinary team of clinicians, researchers, and manufacturing specialists throughout the treatment process.
The strength of this approach has been demonstrated beyond melanoma (搜索). Research published in the journal Haematologica showed that Sheba's locally manufactured CAR-T therapy (搜索) achieved a 98.8% manufacturing success rate and an 11-day vein-to-vein time, compared with 38 to 44 days for commercial products. Despite treating patients with more advanced disease characteristics, clinical outcomes remained comparable to commercial CAR-T therapies.
Beyond Melanoma (搜索): A Comprehensive Cellular Therapy Ecosystem
Under the leadership of Prof. Arnon Nagler, President of the Hemato-Oncology Center, Sheba continues to advance point-of-care CAR T-cell therapy for hematologic malignancies while pioneering research into CAR-T treatment for severe autoimmune diseases. This broader cellular therapy ecosystem reinforces the center's expertise and infrastructure, benefiting patients across multiple disease areas.
Supporting International Patients
For German and Austrian physicians seeking advanced treatment options not yet widely available locally, Sheba offers a dedicated support system for international patients from referral through recovery. Every international patient is assigned a personal Global Patient Services coordinator who serves as a single point of contact throughout treatment. Coordinators provide assistance in the patient's native language, translate medical information and physician instructions, and help ensure clear communication at every step. The team also assists with travel logistics, including guidance on visas, transportation, and accommodations for patients and their families.
As advanced cellular therapies continue transforming the treatment of cancer and autoimmune diseases, Sheba's integrated model—combining laboratory research, in-house manufacturing, clinical trials, and patient care—demonstrates how specialized infrastructure and multidisciplinary expertise can help bridge access gaps for patients across Europe and beyond.