Atezolizumab AND Hyaluronidase-tqjs · Regulatory label update

FDA supplemental approval: Tecentriq Hybreza (Efficacy)

U.S. Food and Drug Administration · May 15, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a supplemental application (BLA761347) for Tecentriq Hybreza, a fixed-dose combination of atezolizumab and hyaluronidase-tqjs, on 15 May 2026. This is a regulatory action record and does not disclose the clinical trial evidence, efficacy endpoints, or comparator data that supported the decision.

What was studied

Regulatory label update. Intervention: Atezolizumab and hyaluronidase-tqjs 125 mg fixed-dose combination injection.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Clinicians should consult the approved package insert and prescribing information for indication, dosing, and efficacy claims. This regulatory record alone does not provide the clinical trial results needed to assess comparative benefit or efficacy magnitude.

Plain-language summary

FDA supplemental approval for a fixed-dose combination formulation; regulatory action does not itself report clinical trial efficacy data or comparative outcomes.

Study design

As stated by the source record.

InterventionAtezolizumab and hyaluronidase-tqjs 125 mg fixed-dose combination injection

Clinical bottom line

Caveats

This is a regulatory action document, not a clinical trial report; no efficacy data, sample size, endpoints, or statistical results are disclosed.
Approval classification is 'Efficacy' but the supporting trial(s), their design, and outcomes are not detailed in this record.
No information on population studied, comparator arm, or hazard ratios, risk reductions, or p-values is provided.
Supplement type is not explicitly stated; unclear whether this is a new indication, formulation, or dosage change relative to prior Tecentriq approval(s).

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory record; no clinical trial design described.

Directness

insufficient

Approval record does not disclose supporting trial endpoints or outcomes.

Consistency

insufficient

No comparative or replication data presented in this record.

Risk of bias

insufficient

Regulatory action; methodological quality not assessed in this document.

Sample adequacy

insufficient

No sample size or trial population data reported in this record.

What is missing. This record has no key findings, reported figures. That is a gap in the analysis, not a judgement about the study.

Source abstract

Drugs@FDA record for application BLA761347. This is a regulatory action record, not a clinical study. Brand name: TECENTRIQ HYBREZA. Active ingredient: ATEZOLIZUMAB AND HYALURONIDASE-TQJS. Sponsor: GENENTECH INC. Submission type: SUPPL (supplement). Submission class: Efficacy. Approval status date: 2026-05-15. Products: TECENTRIQ HYBREZA, INJECTABLE, INJECTION, ATEZOLIZUMAB AND HYALURONIDASE-TQJS 125MG.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Atezolizumab AND Hyaluronidase-tqjsGenentech