TriangleSTATUS · fda-aa-1b653aa9cbb1875e6d30
Zenbexus (iberdomide)
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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 daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
- Source status category
- ongoing
- Event date
- 2026-08-13
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2026-08-13
- accelerated approval date source text
- 8/13/2026
- brand name hint
- Zenbexus
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Zenbexus (iberdomide)
- generic name hint
- iberdomide
- id
- fda-aa-1b653aa9cbb1875e6d30
- indication exact
- In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
- original projected completion source text
- 5/31/2028
- post marketing requirement exact
- 5041-1: Complete a randomized controlled trial of iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone compared to daratumumab and hyaluronidase-fihj and dexamethasone and bortezomib in patients with relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and secondary endpoints should include overall survival and overall response rate.
- record type
- fda_accelerated_approval_status_row
- source cells exact
- links
- text
- Zenbexus (iberdomide)
- links
- /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone
- text
- In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
- links
- text
- 8/13/2026
- links
- text
- 5041-1: Complete a randomized controlled trial of iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone compared to daratumumab and hyaluronidase-fihj and dexamethasone and bortezomib in patients with relapsed or refractory multiple myeloma. The primary endpoint should be progression-free survival and secondary endpoints should include overall survival and overall response rate.
- links
- text
- 5/31/2028
- 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
- 3
- 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
- 2026-08-13
- 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
- Zenbexus (iberdomide)
- fda status record id
- fda-aa-1b653aa9cbb1875e6d30
- indication exact
- In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-47e1257c83ae1092bee6
- ind-span-a57c67a2f2c956cfab01
- 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-b98bcb5f724c03be5c64fbf9
- span id
- ind-span-47e1257c83ae1092bee6
- status id
- fda-aa-1b653aa9cbb1875e6d30
- 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
- 293
- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE ZENBEXUS is indicated, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
- label id
- 05b6e27f-40ba-4939-a0c3-8e8ae1feae98
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 7a19ab342663a731922f28ebba663b0d8fd3d0e976fc9405818204ff77462585
- start
- 0
- fda indication exact
- In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
- fda source row index
- 3
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-1b653aa9cbb1875e6d30
- 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
- 2026-08-13
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-df73d995d01797d2e7b5d766
- span id
- ind-span-a57c67a2f2c956cfab01
- status id
- fda-aa-1b653aa9cbb1875e6d30
- 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
- 909
- end exclusive
- true
- exact text
- ZENBEXUS is a cereblon-modulating protein degrader indicated in combination with daratumumab and hyaluronidase-fihj and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
- label id
- 05b6e27f-40ba-4939-a0c3-8e8ae1feae98
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 7a19ab342663a731922f28ebba663b0d8fd3d0e976fc9405818204ff77462585
- start
- 603
- fda indication exact
- In combination with daratumumab and hyaluronidase-fihj and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent
- fda source row index
- 3
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-1b653aa9cbb1875e6d30
- 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
- 2026-08-13
- supporting anchor spans
Preserved source evidence · Not medical advice