Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

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…

ByRidhi RastogiMay 18, 2026

The US FDA New Drug Approvals in September 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of September 2024 The US FDA has approved a total of 7 new drugs including 4 new molecular entities and 3 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drugs were Roche’s Tecentriq Hybreza & Ocrevus Zunovo for…

ByDipanshu DixitOctober 22, 2024

Roche’s Tecentriq Hybreza Receives the US FDA’s Approval for Cancer Treatment

Shots: The US FDA has approved Tecentriq Hybreza (SC) to treat all IV indications, incl. lung, liver, skin & soft tissue cancers. Regulatory reviews across other regions are underway The approval was supported by P-IB/III (IMscin001) study assessing Tecentriq Hybreza (SC) vs Tecentriq (IV) in locally advanced or metastatic NSCLC patients (n=371) failed on…

ByDipanshu DixitSeptember 13, 2024

Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

The US FDA New Drug Approvals in September 2024

Roche’s Tecentriq Hybreza Receives the US FDA’s Approval for Cancer Treatment

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