As the American Urological Association (AUA) annual meeting prepares to kick off on May 12, newly published prostate cancer guidelines recommend two tests to help clinicians and patients determine the best path forward for treatment—or waiting. The latest AUA guidelines incorporated Exact Sciences Corp.’s Oncotype DX Genomic Prostate Score (GPS) test for risk-stratification of localized prostate cancer, while the National Comprehensive Cancer Network (NCCN) added Cleveland Diagnostics Inc.’s Isopsa test to help identify high-grade early prostate cancer before a biopsy or after a negative biopsy result.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
Boston Scientific Corp. sent warning notices of the potential for embolisms arising from use of its Spaceoar and Spaceoar Vue systems because of “inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis.”
Modra Pharmaceuticals BV is planning to move its oral formulation of docetaxel into a pivotal trial, hoping to offer advanced prostate cancer patients a safer treatment option than intravenous chemotherapy. The Amsterdam, the Netherlands-based company has just announced phase IIb results in metastatic castration-resistant prostate cancer from ModraDoc-006/r, a tablet containing docetaxel and co-administered with ritonavir to enhance bioavailability.
The U.S. FDA has granted Datar Cancer Genetics Ltd. a breakthrough device designation for a blood test to detect early-stage prostate cancer. The circulating tumor cell (CTC) detection blood test can identify early-stage prostate cancer in men of age 55-69 years at around 99% accuracy.
A Japanese study has shown that targeting the chemokine receptor CCR4 using treatment with the monoclonal antibody mogamulizumab (Poteligeo, Kyowa, Amgen) depleted immune regulatory T cells and significantly improved survival in a canine model of advanced prostate cancer.
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Telix Pharmaceuticals Ltd.’s lead prostate cancer imaging agent, Illuccix. Illuccix (TLX591-CDx) is a Gallium-based PSMA imaging agent and cold kit for developing radiopharmaceutical products and diagnostic agents. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX-591) to improve the detection and treatment of prostate cancer.