Curium Gains Swiss Approval For PYLCLARI® PSMA PET Imaging Agent In Prostate Cancer

Curium announced that it has received marketing authorisation in Switzerland for PYLCLARI® (Piflufolastat (18F), formerly known as (18F)-DCFPyL), a PSMA-targeted PET imaging agent used to detect prostate cancer lesions. PYLCLARI® is approved for two clinical uses: primary staging of high-risk prostate cancer before curative treatment and localizing recurrence in patients with rising PSA levels following initial treatment.

Dr. Michel Wuillemin, Managing Director at b.e. Imaging stated, “b.e. Imaging has proven to be a crucial supplier for the whole range of Curium’s SPECT radiopharmaceuticals for Switzerland. The extension of the partnership with Curium to PSMA PET imaging with PYLCLARI® underscores b.e. Imaging’s focus in the field of prostate cancer. Curium’s PYLCLARI® is in line with b.e. Imaging’s experience in the field of radioligand therapy for patients with prostate cancer.”

The Swiss approval follows the European Commission’s 2023 authorization for use across the EU. Curium’s distribution partner in Switzerland, b.e. Imaging, which already handles Curium’s SPECT radiopharmaceuticals, will now exclusively distribute PYLCLARI® as part of an agreement made in September 2023. This marks the 12th country in Europe where PYLCLARI® is available for prostate cancer patients. 

Benoit Woessmer, PET Europe CEO at Curium said, “We are pleased with the growing availability of PYLCLARI® to reach more nuclear medicine physicians and their patients across Europe. With today’s announcement, we are extremely proud to be improving the choice of diagnostic radiopharmaceuticals available to our customers in Switzerland – ultimately for the benefit of patients with prostate cancer.”

With approximately 7,800 new prostate cancer diagnoses annually in Switzerland, this approval represents a significant step in improving diagnostic precision and treatment planning. In the U.S., the same compound is marketed as PYLARIFY®, approved by the FDA in 2021 and currently the leading PSMA PET imaging agent. Curium obtained European rights to the radiotracer from Progenics, a Lantheus company, in 2018.