TriangleSTATUS · fda-aa-2166d78188bbe85e0ffd
Monjuvi (tafasitamab-cxix)
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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
In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- Source status category
- ongoing
- Event date
- 2020-07-31
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2020-07-31
- accelerated approval date source text
- 7/31/2020
- brand name hint
- Monjuvi
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Monjuvi (tafasitamab-cxix)
- generic name hint
- tafasitamab-cxix
- id
- fda-aa-2166d78188bbe85e0ffd
- indication exact
- In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- original projected completion source text
- 12/31/2025
- post marketing requirement exact
- 3904-1: Submit the final report and datasets from a randomized, Phase 3 clinical trial to verify the clinical benefit of tafasitamab in patients with DLBCL. The trial should include sufficient numbers of racial and ethnic minority patients to better reflect the U.S. patient population and allow for the interpretation of the results in these patient populations. Patients should be randomized to receive immunotherapy and/or chemotherapy with or without tafasitamab and lenalidomide. The primary endpoint should be PFS, with secondary endpoints that include OS and ORR.
- record type
- fda_accelerated_approval_status_row
- related fda urls
- source cells exact
- links
- text
- Monjuvi (tafasitamab-cxix)
- links
- text
- In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- links
- text
- 7/31/2020
- links
- text
- 3904-1: Submit the final report and datasets from a randomized, Phase 3 clinical trial to verify the clinical benefit of tafasitamab in patients with DLBCL. The trial should include sufficient numbers of racial and ethnic minority patients to better reflect the U.S. patient population and allow for the interpretation of the results in these patient populations. Patients should be randomized to receive immunotherapy and/or chemotherapy with or without tafasitamab and lenalidomide. The primary endpoint should be PFS, with secondary endpoints that include OS and ORR.
- links
- text
- 12/31/2025
- 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
- 49
- source table headers
- Drug Name
- Accelerated Approval (AA) Indication
- AA Date
- AA Post-Marketing Requirement
- Original Projected Completion 1
- source table index
- 0
- 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
- 2020-07-31
- 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
- Monjuvi (tafasitamab-cxix)
- fda status record id
- fda-aa-2166d78188bbe85e0ffd
- indication exact
- In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-13ff7388654846d52f65
- ind-span-a41d219b756ecaef440e
- 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
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-e49627cfdd8ec6fe32227feb
- span id
- ind-span-a41d219b756ecaef440e
- status id
- fda-aa-2166d78188bbe85e0ffd
- match method
- whole_indication_literal_normalized_substring
- scope relationship
- whole_fda_indication_text_present
- matching review status
- source_comparison_only_clinical_review_pending
- payload
- candidate source span
- end
- 914
- end exclusive
- true
- exact text
- MONJUVI is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- label id
- 49d73fc8-03e2-8b9c-e063-6294a90a3a97
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- bd9ca75c177a7f14fe35ae626fd8ad69e72580ab83172761f96c45ed1f058700
- start
- 581
- fda indication exact
- In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- fda source row index
- 49
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-2166d78188bbe85e0ffd
- 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
- 2020-07-31
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-ef010643e067f7420dbaca95
- span id
- ind-span-13ff7388654846d52f65
- status id
- fda-aa-2166d78188bbe85e0ffd
- match method
- whole_indication_literal_normalized_substring
- scope relationship
- whole_fda_indication_text_present
- matching review status
- source_comparison_only_clinical_review_pending
- payload
- candidate source span
- end
- 358
- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- label id
- a70f85e0-c22b-419a-9be2-51f575932633
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- b9462e940ac5f59f63e0b60ece3b0ca2f3287aa3ae77f5cd3e7d512592511909
- start
- 0
- fda indication exact
- In combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
- fda source row index
- 49
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-2166d78188bbe85e0ffd
- 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
- 2020-07-31
- supporting anchor spans
Preserved source evidence · Not medical advice