First marketing authorization for RoTecPSMA®

We are thrilled to announce that RoTecPSMA^® has been approved in the United Kingdom!

RoTecPSMA^® is a technetium-99m cold kit for SPECT imaging of prostate cancer patients and the first PSMA-SPECT tracer approved in a European country. It marks a significant step forward in closing a gap in patient care, making advanced diagnostics more accessible for those affected by prostate cancer.

Prof. Dr. med. Ken Herrmann (University Hospital Essen) emphasizes the importance of this approval:

„The MHRA approval of RoTecPSMA^® (^99mTc-MIP-1404) is the first regulatory approval of a ^99mTc-PSMA agent worldwide by a major regulatory body. This is an important milestone as despite the success of multiple PSMA PET agents there is still a lack of access to PSMA imaging in many parts of the world. The rising demand for PSMA scans is already causing delays for men who urgently require a scan to guide their clinical treatment. It’s fantastic news that RoTecPSMA^® can now help fill this gap and enhance access to care. I’m sure there is more (both indications as well as ^99mTc-PSMA tracers) to come.“

The significance of this development is further underscored by Prof. Dr. med. Thorsten Derlin (Hannover Medical School), who highlights the impact on patient eligibility for advanced treatments:

„Access to PSMA imaging prior to PSMA Radioligand therapy (RLT) is still a major challenge in many European countries. We have successfully shown that 99mTc-MIP-1404 SPECT/CT is suitable for assessment of eligibility for PSMA RLT in patients with advanced mCRPC (Derlin et al. 2025 JNM). Having now a PSMA-SPECT tracer approved is a great success.“

ROTOP’s CEO, Jens Junker, also recognizes the dedication and perseverance that made this milestone possible:

„This is an extraordinary achievement and a defining moment in ROTOP’s history. I want to express my sincere gratitude and congratulations to everyone who contributed to this success. Most importantly, the approval of RoTecPSMA^® enables us to provide prostate cancer patients with better access to this essential diagnosis, ultimately improving their chances for timely and effective treatment.“

More information at MHRA:  https://www.gov.uk/government/news/