STATUS · fda-aa-acf999b5dcbb789c416e

Hernexeos (zongertinib)

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This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test

Source status category: ongoing
Event date: 2026-02-26
Meaning of this date: Original accelerated approval date; ongoing status observed at source retrieval

accelerated approval date

2026-02-26

accelerated approval date source text

2/26/2026

brand name hint

Hernexeos

date change comparison status

no_previous_normalized_snapshot_supplied

date change from prior snapshot

Source null

drug name exact

Hernexeos (zongertinib)

generic name hint

zongertinib

fda-aa-acf999b5dcbb789c416e

indication exact

original projected completion source text

11/30/2029

post marketing requirement exact

4881-1: Complete the ongoing multicenter, randomized clinical trial, Study Beamion LUNG-2, intended to verify and describe the clinical benefit of zongertinib in adult patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.

record type

fda_accelerated_approval_status_row

related fda urls

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell

source cells exact

links
text
Hernexeos (zongertinib)
links
/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
text
Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test
links
text
2/26/2026
links
text
4881-1: Complete the ongoing multicenter, randomized clinical trial, Study Beamion LUNG-2, intended to verify and describe the clinical benefit of zongertinib in adult patients with advanced, unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.
links
text
11/30/2029

source provenance

bytes: 102185
effective url: https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
file: /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
http status: 200
requested url: https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
retrieved at: 2026-09-09T23:35:15.160724+00:00
sha256: 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
source page date Modified text: Wed, 09/09/2026 - 00:00
source page date Published text: Wed, 09/09/2026 - 12:45

source row index

source table headers

Drug Name
Accelerated Approval (AA) Indication
AA Date
AA Post-Marketing Requirement
Original Projected Completion 1

source table index

source url

https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals

status applies to

This exact indication and regimen, not every use of this drug

status category

ongoing

status event date

2026-02-26

status event date meaning

Original accelerated approval date; ongoing status observed at source retrieval

traditional approval date

Source null

verification flags

verification status

official_fda_status_table_extracted_indication_matching_not_clinically_reviewed

withdrawal date

Source null

Source correspondence records

matching

drug name exact

Hernexeos (zongertinib)

fda status record id

fda-aa-acf999b5dcbb789c416e

indication exact

match status

source_correspondence_found_clinical_review_pending

matched candidate ids

ind-span-bfea82b7468f697ec43a
ind-span-77954d03955f6ba18bc0

source provenance

bytes: 102185
effective url: https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
file: /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
http status: 200
requested url: https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
retrieved at: 2026-09-09T23:35:15.160724+00:00
sha256: 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
source page date Modified text: Wed, 09/09/2026 - 00:00
source page date Published text: Wed, 09/09/2026 - 12:45

source url

https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals

status category

ongoing

unmatched meaning

Source null

links

package id
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correspondence id
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span id
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status id
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match method
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scope relationship
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matching review status
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payload
candidate source span
end
317
end exclusive
true
exact text
1 INDICATIONS AND USAGE HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test [see Dosage and Administration (2.1) ] .
label id
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offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
a579a198d797d877aa65daa1ab0cd7acfc599d21504a64a6e96953599ac34b41
start
0
fda indication exact
Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test
fda source row index
6
fda source sha256
8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
fda status record id
fda-aa-acf999b5dcbb789c416e
interpretation
Source wording correspondence to a dated FDA status row; current approval not certified
match method
whole_indication_literal_normalized_substring
matching review status
source_comparison_only_clinical_review_pending
scope relationship
whole_fda_indication_text_present
source url
https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
status category
ongoing
status event date
2026-02-26
supporting anchor spans
package id
fda-label-library-8184721b7b3bb86692f8276c
correspondence id
correspondence-631171c6e7b278b4babad454
span id
ind-span-77954d03955f6ba18bc0
status id
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match method
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scope relationship
whole_fda_indication_text_present
matching review status
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payload
candidate source span
end
870
end exclusive
true
exact text
HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
label id
0fd3e81b-38c9-4d19-b075-9256049a9d41
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
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start
598
fda indication exact
Treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test
fda source row index
6
fda source sha256
8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
fda status record id
fda-aa-acf999b5dcbb789c416e
interpretation
Source wording correspondence to a dated FDA status row; current approval not certified
match method
whole_indication_literal_normalized_substring
matching review status
source_comparison_only_clinical_review_pending
scope relationship
whole_fda_indication_text_present
source url
https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
status category
ongoing
status event date
2026-02-26
supporting anchor spans

Preserved source evidence · Not medical advice