USFDAJun 11, 2026, 08:31 AM
Alpha Tau resumes REGAIN trial enrollment for GBM; FDA clears 7 patients
AI Summary
Alpha Tau Medical Ltd. announced that the U.S. FDA has cleared the company to immediately resume enrollment for the final seven patients in its U.S. REGAIN trial for recurrent glioblastoma (GBM). This clearance follows a positive interim safety report from the first three patients, who showed 100% local disease control and a 67% complete response rate with only one manageable serious adverse event. Additionally, two new leading U.S. academic cancer centers have been authorized to join the trial, expanding access and expertise for this critical indication.
Key Highlights
- FDA cleared Alpha Tau to enroll final 7 patients in U.S. REGAIN trial for recurrent glioblastoma.
- Interim safety report reviewed for the first 3 patients treated between December 2025 and March 2026.
- First 3 patients demonstrated 100% local disease control and a 67% complete response rate.
- Only one associated grade 3 serious adverse event was observed, which fully resolved.
- Two additional leading U.S. academic cancer centers are now approved to participate in the REGAIN trial.
- Alpha DaRT received FDA Breakthrough Device Designation in October 2021 for recurrent glioblastoma.
- Alpha Tau was accepted into the FDA's TPLC Advisory Program (TAP) Pilot in October 2024.
- Approximately 14,000 Americans are newly diagnosed with glioblastoma each year.
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