Trastuzumab AND Hyaluronidase-oysk · Regulatory label update

FDA supplemental approval: Herceptin Hylecta (Labeling)

U.S. Food and Drug Administration · May 18, 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 for labeling changes to Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) on 18 May 2026. This record documents a regulatory action only and does not contain clinical trial results, efficacy data, or safety findings that would support clinical decision-making.

What was studied

Regulatory label update.

Key findings

Safety

This record does not contain clinical trial data, efficacy results, or safety findings.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval for labeling of Herceptin Hylecta; this is a regulatory action record, not a clinical evidence trial.

Reported figures

Quoted from the source exactly as published.

Approval date2026-05-18

Product strength600 MG

Route of administrationSubcutaneous injection

Caveats

This record does not contain clinical trial data, efficacy results, or safety findings.
Specific labeling changes approved are not described in this record.
No comparative effectiveness or patient outcome data are reported.
The nature and scope of the labeling supplement are not specified.

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

This is a regulatory record, not a clinical study.

Directness

insufficient

Regulatory approval action; clinical efficacy not reported here.

Consistency

insufficient

No trial outcome data provided in this record.

Risk of bias

insufficient

Not applicable to a regulatory labeling supplement.

Sample adequacy

insufficient

No patient sample or trial population described.

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

Source abstract

Drugs@FDA record for application BLA761106. This is a regulatory action record, not a clinical study. Brand name: HERCEPTIN HYLECTA. Active ingredient: TRASTUZUMAB AND HYALURONIDASE-OYSK. Sponsor: GENENTECH INC. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-05-18. Products: HERCEPTIN HYLECTA, INJECTABLE, SUBCUTANEOUS, TRASTUZUMAB AND HYALURONIDASE-OYSK 600MG.

Follow from this

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

Trastuzumab AND Hyaluronidase-oyskGenentech