Trastuzumab Deruxtecan — drug

Regulatory

Approvals (21)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory21 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2026-05-15 (see label)	approved	May 15, 2026	openfda
US FDA	—	Efficacy supplement 2026-05-15 (see label)	approved	May 15, 2026	openfda
US FDA	—	Efficacy supplement 2026-04-27 (see label)	approved	Apr 27, 2026	openfda
US FDA	—	Efficacy supplement 2025-12-15 (see label)	approved	Dec 15, 2025	openfda
US

Data updated 16 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	11	5	2	12	21	US	Dec 20, 2019	Nov 12, 2020
Malignant Breast Neoplasm	Approved	Phase 3	6	2	1	6	6	US	Dec 20, 2019	Nov 12, 2020
Malignant Lung Neoplasm	Approved	Phase 2	2	1	0	2	1	US	Dec 20, 2019	Nov 12, 2020
Malignant Bladder Neoplasm	Phase2	Phase 2	1	0	0	1	0

Curated evidence

Clinical evidence (24)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–24 of 24 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ERBB4 Fusion1
Mobocertinib + Osimertinib

Clinical trials

Trials with this intervention (14)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–14 of 14 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04644068	Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies(PETRA)	active not recruiting	Phase 1 / Phase 2	702	AstraZenecaINDUSTRY	14	Sep 21, 2026	clinicaltrials
NCT07828054	Premedication With Dexamethasone for Preventing Interstitial Lung Disease in Patients With Breast Cancer Treated With Trastuzumab Deruxtecan

ERBB2 Exon 20 Insertion2
Trastuzumab Deruxtecan	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11765 In a phase 2 trial, 152 metastatic NSCLC patients harboring mutations in ERBB2 (HER2) treated with 2 different doses of the HER2 ADC trastuzumab deruxtecan (5.4 mg/kg and 6.4 mg/kg) resulted in clinic… (full text at CIViC) PMID 37694347 · Goto et al., 2023 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID10140 In a phase 2 trial, 91 patients with ERBB2-mutant metastatic non-small-cell lung cancer, refractory to standard treatment, were treated with trastuzumab deruxtecan. The objective response was 55% (95%… (full text at CIViC) PMID 34534430 · Li et al., 2022 · Open in CIViC	civic