FDA to Review Wearable Furosemide Delivery System for Outpatient Use
Furoscix is a wearable, pre-programmed on-body furosemide delivery system for outpatient self-administration.
Furoscix is a wearable, pre-programmed on-body furosemide delivery system for outpatient self-administration.
The source of the chemicals is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines.
The decision to discontinue was based on data from pre-planned analyses of the phase 3 PIVOT-09 study and the phase 2 PIVOT-10 study.
Camcevi is a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone agonist.
Cohort 3 of the phase 2 TROPHY-U-01 trial evaluated sacituzumab govitecan plus pembrolizumab in checkpoint inhibitor-naive adults with metastatic urothelial cancer who progressed after platinum-based chemotherapy.
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
At a median follow-up of 12 weeks, results showed that the composite response rate was 23%.
The NDA submission included data from 36 clinical trials involving over 8000 patients.
The phase 3 LEAP-011 study evaluated pembrolizumab plus lenvatinib vs placebo in 441 adults with histologically confirmed, locally advanced or metastatic urothelial carcinoma.
The investigational product targets CD70, which is highly expressed in renal cell carcinoma with limited normal tissue expression.