LABELS · 515e94c3-ab8d-4c35-8e7c-7083fd423d60

Denosumab-BMWO

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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: 2026-02-05
Captured: 2026-09-09T23:37:47.659725+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Denosumab-bmwo is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Denosumab-bmwo is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Full extracted label fields

application numbers

BLA761404

boxed warning exact

brand names

Denosumab-BMWO

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d378622d-3a13-4918-ae18-3375cd10d270

generic names

DENOSUMAB-BMWO

515e94c3-ab8d-4c35-8e7c-7083fd423d60

indications and usage exact

1 INDICATIONS AND USAGE Denosumab-bmwo is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Denosumab-bmwo is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

indications and usage tables exact

is original packager

true

manufacturer names

CELLTRION USA, Inc.

matched search terms

myeloma
tumor
tumors
malignancy

package ndcs

72606-059-01

product ndcs

72606-059

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

SUBCUTANEOUS

rxcuis

2717866

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00300.json

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

application numbers

BLA761404

brand names

Denosumab-BMWO

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

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content role

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context span

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exact text: 1 INDICATIONS AND USAGE Denosumab-bmwo is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Tr
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generic names

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qualifier mentions

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exact text: 1 INDICATIONS AND USAGE Denosumab-bmwo is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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spl effective date

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spl set id

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spl version

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regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 2 · positive indication candidate

application numbers

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exact text: USAGE Denosumab-bmwo is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the pr
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qualifier mentions

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source url

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spl effective date

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structured indication

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disease stage: Source null
limitations: Source null
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prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

tumor_directed_candidate

Passage 3 · unclassified context

application numbers

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brand names

Denosumab-BMWO

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clinical review status

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exact text: rom solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bon
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positive predicate support span

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qualifier mentions

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source url

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spl effective date

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spl set id

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structured indication

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limitations: Source null
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regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

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brand names

Denosumab-BMWO

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exact text: l tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metast
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exact text: ( 1.3 )
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source url

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use intent

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Passage 5 · positive indication candidate

application numbers

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brand names

Denosumab-BMWO

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clinical review status

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exact text: of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Denosumab-bmwo is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection i
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1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events
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Metastasis from Solid Tumors Denosumab-bmwo
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in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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exact text: 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
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Passage 6 · positive indication candidate

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exact text: d Bone Metastasis from Solid Tumors Denosumab-bmwo is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Denosumab-bmwo is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
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exact text: 1.2 Giant Cell Tumor of Bone Denosumab-bmwo is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] .
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source text sha256: 5fb0528acd9d66a868ed4753327ee6941176b553ed7664880118830cc4de6b96
start: 724

source url

https://api.fda.gov/drug/label.json?search=id%3A%22515e94c3-ab8d-4c35-8e7c-7083fd423d60%22

spl effective date

2026-02-05

spl set id

d378622d-3a13-4918-ae18-3375cd10d270

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

tumor_directed_candidate

Passage 7 · positive indication candidate

application numbers

BLA761404

brand names

Denosumab-BMWO

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1140
end exclusive: true
exact text: ment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity [see Clinical Trials (14.2) ] . 1.3 Hypercalcemia of Malignancy Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
label id: 515e94c3-ab8d-4c35-8e7c-7083fd423d60
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source field: indications_and_usage_exact
source text sha256: 5fb0528acd9d66a868ed4753327ee6941176b553ed7664880118830cc4de6b96
start: 794

current approval status

not_reconciled

duplicate text group

dup-a5e496531f9ef8c652d3

extraction review status

automated_candidate_pending_source_review

generic names

DENOSUMAB-BMWO

ind-span-3f90d6ce10e1822c9e52

label id

515e94c3-ab8d-4c35-8e7c-7083fd423d60

positive predicate support span

end: 1053
end exclusive: true
exact text: is indicated
label id: 515e94c3-ab8d-4c35-8e7c-7083fd423d60
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source array index: 0
source field: indications_and_usage_exact
source text sha256: 5fb0528acd9d66a868ed4753327ee6941176b553ed7664880118830cc4de6b96
start: 1041

qualifier mentions

context exact
indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
kind
stage_or_setting
polarity
not_inferred
span
end
1139
end exclusive
true
exact text
refractory to bisphosphonate therapy
label id
515e94c3-ab8d-4c35-8e7c-7083fd423d60
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
5fb0528acd9d66a868ed4753327ee6941176b553ed7664880118830cc4de6b96
start
1103

regulatory links

schema version

0.1.0

source batch sha256

bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e

source defined aliases

source span

end: 1140
end exclusive: true
exact text: 1.3 Hypercalcemia of Malignancy Denosumab-bmwo is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
label id: 515e94c3-ab8d-4c35-8e7c-7083fd423d60
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: 5fb0528acd9d66a868ed4753327ee6941176b553ed7664880118830cc4de6b96
start: 994

source url

https://api.fda.gov/drug/label.json?search=id%3A%22515e94c3-ab8d-4c35-8e7c-7083fd423d60%22

spl effective date

2026-02-05

spl set id

d378622d-3a13-4918-ae18-3375cd10d270

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

supportive_care_candidate

Preserved source evidence · Not medical advice