Pangea Laboratory and Unilabs have announced a strategic collaboration to introduce the Bladder CARE Assay, an advanced non-invasive diagnostic tool for early detection of bladder cancer and Upper Tract Urothelial Carcinoma (UTUC), in Switzerland. This partnership represents a transformative step in oncological diagnostics within the region, offering a more patient-centric and effective solution compared to […]
In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded priority review status to its Supplemental New Drug Application (sNDA) for PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for adults with previously untreated locally advanced […]
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated […]
Ferring Pharmaceuticals has announced that the first patient in the United States suffering from high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) has been administered with the intravesical gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg). The gene therapy was approved by the U.S. Food and Drug Administration (FDA) in December 2022 for the treatment of adult […]
Promis Diagnostics has secured breakthrough device designation for its non-invasive EarlyTect BCD test from the US Food and Drug Administration (FDA) as a urine-based diagnosis of bladder cancer from hematuria patients. Hematuria is considered a frequent indicator of bladder cancer. The EarlyTect BCD test is designed to qualitatively identify PENK methylation, a single epigenetic biomarker […]
Swiss biopharmaceutical company Ferring Pharmaceuticals has received approval for its Adstiladrin (nadofaragene firadenovec-vncg) gene therapy from the US Food and Drug Administration (FDA) for the treatment of a type of bladder cancer in adult patients. Adstiladrin, which is an adenovirus vector-based gene therapy, is indicated for treating high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) […]
Aura Biosciences said that it has dosed the first patient in a phase 1 clinical trial of its first virus-like drug conjugate (VDC) — belzupacap sarotalocan for the treatment of non-muscle invasive bladder cancer (NMIBC). According to the NASDAQ-listed clinical-stage biotech company, the early-stage multi-center, open label study is likely to take in nearly 23 […]
Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration (FDA) for the treatment of non-muscle invasive bladder cancer (NMIBC). Belzupacap sarotalocan is the first virus-like drug conjugate (VDC) being developed by the American biotech company for various oncology indications. Dr. Mark De Rosch — Aura Biosciences […]
PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) has been given breakthrough therapy designation from the US Food and Drug Administration (FDA) in first-line advanced bladder cancer. The FDA breakthrough therapy status for PADCEV, KEYTRUDA combination is for the treatment […]
Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial cancer, the most common form of bladder cancer. Padcev, which has been co-developed by the two pharma companies, is a Nectin-4-directed antibody and microtubule […]