Acceletd Approval Trodelvy - Advanced/Metastatic Urothelial Cancer April 2021

2 years 1 month ago #60717 by Jack R
U.S. FDA Grants Accelerated Approval to Trodelvy forthe Treatment of Metastatic Urothelial Cancer

Gilead Sciences, Inc. Apr 13, 2-21 today announced that theU.S. Food and Drug Administration (FDA) has granted accelerated approval
of  Trodelvy  ( sacituzumab govitecan -hziy)for use in adult patients with locally advanced or metastatic urothelial cancer
(UC) who have previously received a platinum-containing chemotherapy and either
a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1)
inhibitor. The accelerated approval was based on data from the international
Phase 2, single-arm TROPHY study. Of the 112 patients who were evaluable for
efficacy, 27.7% of those treated with Trodelvy responded to treatment, with
5.4% experiencing a complete response and 22.3% experiencing a partial
response. The median duration of response was 7.2 months (95% CI: 4.7-8.6). The
Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or
life-threatening neutropenia and severe diarrhea; see below for Important
Safety Information.More at:

6/2015 HG Papillary & CIS
3 Years and 30 BCG/BCG+Inf
Tis CIS comes back.
BC clear as of 5/17 !
RCC found in my one & only kidney 10/17
Begin Chemo; Cisplatin and Gemzar
8/18 begin Chemo# 3
Begin year 4 with cis
2/19 Chemo #4
9/19 NED again :)
1/2020 CIS is back
Tried Keytruda, stopped by side effects
Workin on a new plan for 2021

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