Update for March 16, 2021

Regulatory Update 


The FDA approved tivozanib (Fotivda, AVEO Oncology), on 3/10/2021, for the treatment of relapsed or refractory renal cell carcinoma following two or more prior lines of therapy.


The FDA accepted the NDA for Cara Therapeutics’ and Vifor Pharma’s difelikefalin for the treatment of moderate-to-severe pruritus in hemodialysis patients and set a PDUFA date for 8/23/2021.


The FDA extended the PDUFA date for belumosudil by three months to allow additional time to review new data submitted by Kadmon. The new PDUFA date is 8/30/2021.


The FDA designated Steba Biotech’s padeliporfin, an Orphan Drug, for the treatment of upper tract urothelial cancer.


Announced Research Updates


Gilead announced that patients who completed the 14-day blinded portion of the CAPELLA trial were enrolled in an open-label extension where they received lenacapavir subcutaneously every six months and an optimized background regimen. After 26 weeks, 73% (19/26) achieved an undetectable viral load (< 50 copies/mL).


Published Research Updates


In a 34 patient, Phase II, open-label trial, treatment with adavosertib resulted in an objective response rate of 29.4% in patients with recurrent uterine serous carcinoma.