LABELS · 492d93a0-02ba-4424-a425-1965749094f6

Lunsumio

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-06-29
Captured: 2026-09-09T23:37:44.904352+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )

Indications and usage: exact source text

1 INDICATIONS AND USAGE LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Full extracted label fields

application numbers

BLA761263

boxed warning exact

WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )

brand names

Lunsumio

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2ef0cf38-101c-4681-98fe-c05dc9ead443

generic names

MOSUNETUZUMAB

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indications and usage exact

1 INDICATIONS AND USAGE LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

indications and usage tables exact

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manufacturer names

Genentech, Inc.

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lymphoma

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50242-159-01

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50242-159

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HUMAN PRESCRIPTION DRUG

recent major changes exact

Dosage and Administration ( 2.1 , 2.3 , 2.5 ) 12/2025 Warnings and Precautions ( 5.1 , 5.5 , 5.7 ) 12/2025

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Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · positive indication candidate

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Read indication-specific status → · whole_fda_indication_text_present

Passage 2 · approval contingency

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exact text: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication
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Passage 4 · unclassified context

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exact text: approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is appro
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SUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
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Read indication-specific status → · whole_fda_indication_text_present

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exact text: This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] .
label id: 492d93a0-02ba-4424-a425-1965749094f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: a27a4387afb4ebc6d1d96b7521b99623c57dd9124a6577c579fe85476f712b9b
start: 622

source url

https://api.fda.gov/drug/label.json?search=id%3A%22492d93a0-02ba-4424-a425-1965749094f6%22

spl effective date

2026-06-29

spl set id

2ef0cf38-101c-4681-98fe-c05dc9ead443

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 7 · approval contingency

application numbers

BLA761263

brand names

Lunsumio

classification reasons

approval_contingency_words

clinical review status

pending

content role

approval_contingency

context span

end: 869
end exclusive: true
exact text: th relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 492d93a0-02ba-4424-a425-1965749094f6
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source array index: 0
source field: indications_and_usage_exact
source text sha256: a27a4387afb4ebc6d1d96b7521b99623c57dd9124a6577c579fe85476f712b9b
start: 531

current approval status

not_reconciled

duplicate text group

dup-5708b8b82cd2191fe961

extraction review status

automated_candidate_pending_source_review

generic names

MOSUNETUZUMAB

ind-span-01074eecca43f4f60355

label id

492d93a0-02ba-4424-a425-1965749094f6

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

d918de6bede8f776ad4fea2bc639292f8454d9733fbbdfdd7fd4414b6200e571

source defined aliases

source span

end: 869
end exclusive: true
exact text: Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
label id: 492d93a0-02ba-4424-a425-1965749094f6
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: a27a4387afb4ebc6d1d96b7521b99623c57dd9124a6577c579fe85476f712b9b
start: 731

source url

https://api.fda.gov/drug/label.json?search=id%3A%22492d93a0-02ba-4424-a425-1965749094f6%22

spl effective date

2026-06-29

spl set id

2ef0cf38-101c-4681-98fe-c05dc9ead443

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice