Shots:
- FDA approved Genentech‘s Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval
- Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA MRD following cystectomy. The surveillance phase enrolled 761 pts, of whom 250 tested ctDNA-positive & entered the treatment phase
- Trial showed Tecentriq reduced the risk of disease recurrence or death by 36% and the risk of death by 41% in patients with detectable ctDNA MRD identified through serial testing within one year of cystectomy
Ref: Genentech | Image: Genentech |Press Release
Related News: Genentech Reports the P-III (METEOROID) Trial Data on Enspryng (Satralizumab) to Treat MOGAD
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