After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Inceptor Bio LLC and Shenzhen Grit Biotechnology Co. Ltd. have established a strategic partnership to advance IB-T101, a CAR T therapy targeting solid tumors.
Scientists from the University of Wisconsin-Madison have reported the discovery of novel carbonic anhydrase IX (CAIX) radioligands for molecular imaging in clear cell renal cell carcinoma (ccRCC).
Nextpoint Therapeutics Inc. has unveiled NPX-372, a novel T-cell engager for solid tumors. NPX-372 is a CD3 bispecific antibody with unique capabilities to redirect T cell-mediated cytotoxicity toward B7-H7-positive tumors such as colorectal carcinoma, non-small-cell lung cancer, renal cell carcinoma and prostate cancer.
Arcus Biosciences Inc. recently disclosed the chemical structure of AB-521 (casdatifan), an orally available small-molecule inhibitor of hypoxia-inducible factor 2α (HIF-2α) in early clinical development for the treatment of advanced solid tumors with a high prevalence of molecular alterations associated with pseudohypoxia, such as clear cell renal cell carcinoma (ccRCC).
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
Researchers from University of Tsukuba published data from a study designed to identify novel biomarkers for predicting treatment responses to nivolumab plus ipilimumab combination therapy.
Aveo Pharmaceuticals Inc., a LG Chem Ltd. subsidiary, said that Fotivda (tivozanib) in combination with Bristol Myers Squibb Co.’s Opdivo (nivolumab) failed to increase progression-free survival (PFS) in advanced kidney cancer patients in a phase III Tinivo-2 study. Despite the primary endpoint miss, Aveo noted that Fotivda alone, or as a monotherapy, in the control arm meaningfully extended median PFS, helping “further support the approved use of Fotivda as a safe and effective treatment option in relapsed or refractory advanced [renal cell carcinoma] RCC following two or more prior systemic therapies.”
