FDA Orphan Drug Designation for Padeliporfin ImPACT in Upper Tract Urothelial Cancer
Barak Palatchi, CEO of Steba Biotech, the IMmune Photo Activate Cancer Treatment (IMPACT) specialist, said, “We are delighted to receive Orphan Drug Designation for Padeliporfin ImPACT in UTUC, further validating Steba’s technology and the benefits our product could bring to people suffering from UTUC. It has been less than a year since we embarked on our new strategy, refocusing Padeliporfin ImPACT on diseases for patients with limited treatment options. In UTUC, the current standard of care is nephrectomy; our hope is that Padeliporfin ImPACT offers these patients an effective treatment option that preserves their kidney. UTUC is the first indication of our ambitious 3-year plan. We are looking forward to exploring the possibility of offering Padeliporfin ImPACT to more patients coping with life threatening cancers.”
Share:
More News
“The initial efficacy data from the Part C studies are consistent with the encouraging efficacy signals we previously reported for Parts A and B of THIO-101, including an 88% disease control rate in third-line NSCLC patients. This measure of efficacy is close to triple the reported outcome for standard-of-care chemotherapy
“Patients with non-muscle invasive bladder cancer continue to face a significant risk of disease recurrence despite available treatment options,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “UGN-501 is an investigational next-generation oncolytic virus designed to selectively destroy tumor cells while generating an anti-tumor immune response. FDA clearance of
“Whitehawk has established strong expertise in ADC technology and oncology drug development,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This collaboration further expands the application of Biocytogen’s fully human bispecific antibodies in ADC development. We look forward to supporting the efficient advancement of multiple programs by contributing high-quality
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The AZUR-1 results support the potential for dostarlimab to transform treatment for dMMR/MSI-H locally advanced rectal cancer. For many patients today, rectal cancer treatment comes with the tolerability burden and lasting impacts from chemotherapy, radiation and surgery. These data