TriangleSTATUS · fda-aa-b902c006dd7cbee0434b
Beqalzi (sonrotoclax)
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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 relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
- Source status category
- ongoing
- Event date
- 2026-05-13
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2026-05-13
- accelerated approval date source text
- 5/13/2026
- brand name hint
- Beqalzi
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Beqalzi (sonrotoclax)
- generic name hint
- sonrotoclax
- id
- fda-aa-b902c006dd7cbee0434b
- indication exact
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
- original projected completion source text
- 9/30/2030
- post marketing requirement exact
- 4994-1: Complete a randomized clinical trial intended to verify and describe the clinical benefit of sonrotoclax in patients with MCL. The trial should randomize patients with relapsed or refractory MCL to receive sonrotoclax in combination with zanubrutinib or placebo in combination with zanubrutinib. The primary endpoint should be PFS as assessed by an independent review committee, with key secondary endpoints that include OS. The trial should include sufficient representation of racial and ethnic populations to reflect the U.S. patient population with MCL and allow for interpretation of the results in these patient populations.
- record type
- fda_accelerated_approval_status_row
- source cells exact
- links
- text
- Beqalzi (sonrotoclax)
- links
- /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma
- text
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
- links
- text
- 5/13/2026
- links
- text
- 4994-1: Complete a randomized clinical trial intended to verify and describe the clinical benefit of sonrotoclax in patients with MCL. The trial should randomize patients with relapsed or refractory MCL to receive sonrotoclax in combination with zanubrutinib or placebo in combination with zanubrutinib. The primary endpoint should be PFS as assessed by an independent review committee, with key secondary endpoints that include OS. The trial should include sufficient representation of racial and ethnic populations to reflect the U.S. patient population with MCL and allow for interpretation of the results in these patient populations.
- links
- text
- 9/30/2030
- 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
- 5
- 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
- 2026-05-13
- 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
- Beqalzi (sonrotoclax)
- fda status record id
- fda-aa-b902c006dd7cbee0434b
- indication exact
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-9084430834f07bb650f6
- ind-span-58c7abfc801be56a5c06
- 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-86cef0a696ca5adea8f30537
- span id
- ind-span-58c7abfc801be56a5c06
- status id
- fda-aa-b902c006dd7cbee0434b
- 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
- 742
- end exclusive
- true
- exact text
- BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
- label id
- 6c13a497-8849-4b37-a84d-692910963567
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 523d08a965fed1ec1d4141ebbf17d5b837ba3fc86800de9c1395b61cbef0e01f
- start
- 513
- fda indication exact
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
- fda source row index
- 5
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-b902c006dd7cbee0434b
- 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
- 2026-05-13
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-aa3319a44fef0bfa91822e8a
- span id
- ind-span-9084430834f07bb650f6
- status id
- fda-aa-b902c006dd7cbee0434b
- 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
- 235
- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
- label id
- 6c13a497-8849-4b37-a84d-692910963567
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 523d08a965fed1ec1d4141ebbf17d5b837ba3fc86800de9c1395b61cbef0e01f
- start
- 0
- fda indication exact
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
- fda source row index
- 5
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-b902c006dd7cbee0434b
- 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
- 2026-05-13
- supporting anchor spans
Preserved source evidence · Not medical advice