On March 23, 2026 Daiichi Sankyo reported ENHERTU (trastuzumab deruxtecan) has been approved in Japan for the treatment of adult patients with HER2 positive (HER2 [ERBB2] gene amplification or immunohistochemistry [IHC] 3+) advanced or recurrent solid cancers refractory or intolerant to standard treatments.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being developed and commercialized by Daiichi Sankyo in Japan.

The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on results from four phase 2 trials, including HERALD, an investigator-initiated trial conducted in Japan, DESTINYPanTumor02, DESTINY-CRC02 and DESTINY-Lung01 where ENHERTU demonstrated clinically meaningful responses across a broad range of tumors. A companion diagnostic (CDx) to test liquid biopsy for HER2 amplification is approved for this new tumor agnostic indication of ENHERTU in Japan. A separate CDx submission to test tumor tissue for HER2 expression (IHC 3+) is planned.

In HERALD, ENHERTU demonstrated a confirmed objective response rate (ORR) of 56.5% (95% confidence interval [CI]: 43.3-69.0) as assessed by investigator in patients (n=62) with unresectable, advanced or recurrent HER2 positive solid cancers refractory or intolerant to standard treatments, including biliary tract, cervical, colorectal, endometrial, esophageal, gastric, melanoma, non-small cell lung (NSCLC), ovarian, pancreatic, prostate, salivary gland, small intestine, urothelial cancer or other tumors.

In DESTINY-PanTumor02, ENHERTU demonstrated a confirmed ORR of 61.3% (95% CI: 49.4-72.4) as assessed by investigator in a subgroup of previously treated patients (n=75) with HER2 positive unresectable advanced or recurrent solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors. In DESTINY-Lung01, ENHERTU demonstrated a confirmed ORR of 52.9% (95% CI: 27.8- 77.0) in a subgroup of patients (n=17) with HER2 positive unresectable or metastatic NSCLC. In DESTINY-CRC02, ENHERTU demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) in a subgroup of patients (n=64) with HER2 positive locally advanced, unresectable or metastatic colorectal cancer.

"This is the first tumor agnostic approval for a HER2 directed medicine and antibody drug conjugate in Japan and marks the sixth approved indication for ENHERTU," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "Based on the clinically meaningful efficacy seen with ENHERTU across numerous types of metastatic cancer, this milestone validates the importance of testing for HER2 across a broad range of tumors

In HERALD, adverse reactions occurred in 59 patients (95.2%) treated with ENHERTU. The most common adverse reactions were nausea (58.1%), decreased appetite (53.2%), fatigue (46.8%), anemia (38.7%), decreased neutrophil count (32.3%), decreased white blood cell count (32.3%), decreased platelet count (24.2%) and stomatitis (22.6%). In DESTINY-PanTumor02, adverse reactions occurred in 65 patients (86.7%) treated with ENHERTU. The most common adverse reactions were fatigue (50.7%), nausea (46.7%), decreased neutrophil count (45.3%), diarrhea (33.3%), anemia (28.0%) and decreased appetite (21.3%). In DESTINY-Lung01, adverse reactions occurred in 17 patients (100%), including two Japanese patients, treated with ENHERTU. The most common adverse reactions were nausea (82.4%), fatigue (52.9%), decreased appetite (35.3%), vomiting (23.5%), diarrhea (23.5%) and anemia (23.5%). In DESTINY-CRC02, adverse reactions occurred in 61 patients (93.8%) treated with ENHERTU. The most common adverse reactions were nausea (56.9%), fatigue (43.1%), decreased neutrophil count (30.8%), diarrhea (23.1%), decreased appetite (23.1%), alopecia (23.1%) and vomiting (20.0%).

ENHERTU is approved in Japan with a Warning in its prescribing information for interstitial lung disease (ILD). ILD occurred in 262 patients (11.6%) treated with ENHERTU across multiple clinical trials. As cases of ILD, including fatal cases, have occurred in ENHERTU-treated patients, ENHERTU is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing regular peripheral artery oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of ENHERTU and take appropriate measures, such as corticosteroid administration. Prior to initiation of ENHERTU therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for ENHERTU therapy.

About HERALD
HERALD is a multicenter, open-label, single-arm, investigator-initiated, phase 2 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in patients with unresectable, advanced or recurrent solid tumors refractory or intolerant to standard treatments and have HER2 gene amplification in circulating tumor DNA, including biliary tract, cervical, colorectal, endometrial, esophageal, gastric, melanoma, NSCLC, ovarian, pancreatic, prostate, salivary gland, small intestine, urothelial cancer or other tumors.

The primary endpoint of HERALD is confirmed ORR as assessed by investigator. Secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), time to treatment failure, overall survival (OS), ORR by independent central review and safety. Results from HERALD were published in the Journal of Clinical Oncology.

HERALD enrolled 62 patients at seven sites in Japan. For more information about the trial, visit Japan’s Registry of Clinical Trials.

About DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label, phase 2 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors.

The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, DCR, PFS, OS, safety, tolerability and pharmacokinetics. Results from DESTINYPanTumor02 were published in the Journal of Clinical Oncology.