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HER2-targeted therapies

Oncologyยท 8 reviewed drugsยท 14311 cited findings behind them

What the regulatory reviews cover

This library includes several HER2-targeted therapies that have undergone regulatory review. These drugs are indicated for various HER2-positive cancers, including breast cancer, non-small cell lung cancer, solid tumors, and biliary tract cancer. The indications range from early-stage and locally advanced disease to metastatic and unresectable conditions, often in patients who have received prior treatments.

Regulatory review documents report a variety of outcomes for these therapies. For example, Enhertu demonstrated an Objective response rate (ORR) of 60.3% in its review. Perjeta showed a PFS Hazard Ratio of 0.62, indicating an improvement in progression-free survival. Tukysa's review noted an OS Hazard Ratio of 0.68. Kadcyla's review reported a Median Progression-free survival of 14.2. It is important to note that these figures are derived from different trials and are not directly comparable head-to-head.

The drugs โ€” one cited result each

Enhertu

Daiichi Sankyo Company, Limited

Objective response rate (ORR): 60.3

Daiichi Sankyo Company, Limited โ€” Enhertu FDA Review (BLA761, p.18

Perjeta

Roche Holding AG

PFS Hazard Ratio: 0.62

Roche Holding AG โ€” Perjeta EMA EPAR public assessment report, p.3

Tukysa

Pfizer Inc.

OS Hazard Ratio: 0.68

Pfizer Inc. โ€” Tukysa FDA Review, p.24

Kadcyla

Roche Holding AG

Median Progression-free survival: 14.2

Roche Holding AG โ€” Kadcyla EMA EPAR public assessment report, p.74

Phesgo

Roche Holding AG

OS improvement with pertuzumab in MBC (CLEOPATRA trial): 16

Roche Holding AG โ€” Phesgo EMA EPAR public assessment report, p.14

Herceptin

Roche Holding AG

patients with Ctrough > 20 ฮผg/mL at pre-dose Cycle 8 (IV arm): 98.7

Roche Holding AG โ€” Herceptin EMA EPAR variation assessment r, p.35

Ziihera

Jazz

Confirmed ORR in Total population: 37.9

Jazz โ€” Ziihera EMA EPAR public assessment report (EMEA/H/C/0, p.130

Tuznue

Prestige Biopharma

Ratio of geometric mean of AUC0-inf (HD201 vs. EU-Herceptin): 102.45 %

Prestige Biopharma โ€” Tuznue EMA EPAR public assessment repor, p.38

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Oncology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

HER2-targeted therapies โ€” 8 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Oncology