“Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer,” Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research, said in press release. “With this first approval of a ...
Dr. Schuster highlights the FDA approval of imaging agent flotufolastat F 18 in prostate cancer Urology Times staff "We're excited that the FDA approval of this radiotracer gives us yet more tools at our disposal to diagnose prostate cancer in all its forms, from early to late in the dis...
Common adverse events on treatment were fatigue, dry mouth, nausea, anaemia, decreased appetite and constipation. The FDA also approved a complementary diagnostic imaging agent, gallium Ga 68 gozetotid, to identify PSMA-positive lesions.doi:10.1038/d41573-022-00067-5Asher Mullard...
Lutetium-177-PSMA-617 is now FDA-approved for the treatment of patients with metastatic castration-resistant prostate cancer who have already received androgen receptor pathway inhibition and taxane-based chemotherapy. The FDA has approved lutetium-177 (177Lu)-PSMA-617 (Pluvicto) to treat patie...
2022年3月,美国食品和药物管理局(FDA)批准Pluvicto用于治疗晚期前列腺癌。在PSMAfore的一项III期研究Pluvicto中,诺华的放射配体疗法显着改善了PSMA阳性转移性去势抵抗性前列腺癌患者的放射学无进展生存期。 Pluvicto(INN:lutetium(177Lu)vipivotide tetraxetan)是一种静脉内放射配体疗法,结合了靶向化合物(配体)和治疗性...
“Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer,” Alex Gorovets, MD, acting deputy director of the Office of Specialty Medicine in FDA’s Center for Drug Evaluation and Research, said in press releasee. “With this first approval of a...
收集周期:12.11-12.15,国内部分为首次申请上市和首次申请临床的创新药 FDA新药获批1、US WorldMeds:eflornithine作用机制:ODC抑制剂适应症:高危神经母细胞瘤12月13日,FDA批准US WorldMeds创新口服维持疗法Iwilfin(eflornithine)的上市申请,用于高危神经母细胞瘤,这是首个也是唯一一个获FDA批准用于神经母细胞瘤的口服维持...
FDA approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. April 22, ...
[14] Ethris Announces Approval of Phase I Clinical Study for ETH47, a First-in-Class InhaledmRNAfor Respiratory Viral Infections. Retrieved November 30, 2023, from网页链接 [15]uniQureAnnounces FDA Clearance of Investigational New Drug Application for AMT-191 Gene Therapy for Fabry Disease. Retriev...
Metastatic prostate cancer has a 5-year survival rate of less than 30%3; mCRPC patients who progress on multiple lines of therapy have limited treatment options FDA approval was based on pivotal Phase III VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plu...