FDA Accepts Supplemental NDA for NUBEQA® (darolutamide) for the Treatment of Patients with Metastatic HSPC
“Bayer is dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease, and today’s acceptance of our sNDA application for NUBEQA plus ADT for the treatment of patients with mHSPC brings us closer to adding an additional treatment option for NUBEQA to benefit those living with mHSPC. If approved, this would expand the indication for NUBEQA in patients with mHSPC to include NUBEQA both with and without chemotherapy, providing physicians and their patients with an additional NUBEQA treatment option in this setting. We are working closely with the FDA to bring this additional NUBEQA treatment option to patients as soon as possible.”, said Christine Roth , Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.
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