Skip to content Skip to footer

Curium Receives FDA Approval for Bexlutry to Treat GEP-NETs

Shots: The US FDA has approved Bexlutry (lutetium Lu 177 dotatate injection) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), covering foregut, midgut, & hindgut NETs Bexlutry is a radioligand equivalent developed through the 505(b)(2) regulatory pathway, targeting Lutathera. The approval is supported by published evidence & targeted bridging data demonstrating…

Read more

Telix Pharmaceuticals

Telix Reports the First Patient Dosing in P-III (LUTEON) Trial of TLX250-Tx for Renal Cancer

Shots: Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC) LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…

Read more

SOFIE Biosciences Reports First Patient Dosing in P-III (FAPI-GO) Trial of [18F]FAPI-74 for Diagnosis of GI Cancer

Shots: SOFIE Biosciences has dosed the first patient with [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical, in the P-III (FAPI-GO) trial for the diagnosis of GI cancers The trial will assess the clinical utility of [¹⁸F]FAPI-74 PET/CT over 24mos. in the detection of metastatic disease in 200 adults with gastroesophageal cancer across 18 sites Another P-III (FAPI-PRO)…

Read more

Sanofi

Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Shots: Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…

Read more