Shots:
- The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab)
- Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved disease-free survival & OS with Tecentriq vs PBO in Signatera-positive MIBC pts
- Trial also showed Signatera-negative pts had a low recurrence risk without adjuvant immunotherapy, with results presented at an ESMO’25, & published in The NEJM
Ref: Businesswire |  Image: Natsera  | Press Release
Related News: Natera Acquires Foresight Diagnostics for ~$450M to Strengthen Ultrasensitive MRD Testing in Solid Tumors & Lymphoma
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