On February 21, 2024 Curium, a world leader in nuclear medicine, reported that the marketing authorization application for PYLCLARI (INN: Piflufolastat (18F) formerly known as (18F)-DCFPyL) submitted by exclusive Swiss distributor b.e.imaging AG on 31 January 2024 to the Swiss Agency for Therapeutic Products (Swissmedic) has been accepted for evaluation (Press release, Curium, FEB 21, 2024, View Source [SID1234640322]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PYLCLARI is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:

Primary staging of patients with high-risk PCa prior to initial curative therapy
To localize recurrence of PCa in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Prostate cancer is one of the most frequently diagnosed cancers in men in Europe, accounting for around 23 percent of all new cancer cases in 2020 and nearly 10 percent of all deaths due to cancer in men.

Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e. imaging commented, "b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI to Swissmedic ahead of schedule. We are fully dedicated to improving the situation of prostate cancer patients in Switzerland."

Benoit Woessmer, PET Europe CEO at Curium commented, "The acceptance of the marketing authorization application by Swissmedic for PYLCLARI is another important milestone for prostate cancer patients in Switzerland. We look forward to providing an improved choice of tools available to physicians for the diagnosis of prostate cancer patients. Importantly, when in full production PYLCLARI is expected to be the most widely available 18F-PSMA tracer in Europe."

The submission to Swissmedic by b.e.imaging AG was based on Curium’s Marketing Authorization Application for (18F)-DCFPyL submitted to the European Medicines Agency in July 2022. Marketing authorization for PYLCLARI (also known as (18F)-DCFPyL) was granted in July 2023 by the European Commission.

b.e.imaging AG currently distributes Curium’s entire suite of SPECT imaging products across Switzerland and has exclusive distribution rights for PYLCLARI in Switzerland. When authorization is received, PYLCLARI will be supplied by three of Curium’s European facilities.

For more information about PYLCLARI: View Source

In the U.S., Lantheus received approval for [18F]-DCFPyL, now PYLARIFY (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021. It is the #1 PSMA PET Imaging Agent in the U.S. market. The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.