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STATUS · fda-aa-f95ec17446197e3c8811

Scemblix (asciminib)

Open original source → · Download preserved record

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 newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

Source status category
ongoing
Event date
2024-10-29
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2024-10-29
accelerated approval date source text
10/29/2024
brand name hint
Scemblix
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Scemblix (asciminib)
generic name hint
asciminib
id
fda-aa-f95ec17446197e3c8811
indication exact
Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
original projected completion source text
6/30/2028
post marketing requirement exact
4724-1:Complete clinical study CABL001J12301 (ASC4FIRST), A Phase 3, Multi-center, Open-label, Randomized Study of Oral Asciminib versus Investigator Selected TKI in Patients with Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase, intended to describe and confirm the clinical benefit of asciminib to include at least 60 months follow-up of all patients.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
source cells exact
  1. links
      text
      Scemblix (asciminib)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-asciminib-newly-diagnosed-chronic-myeloid-leukemia
      text
      Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
    2. links
        text
        10/29/2024
      1. links
          text
          4724-1:Complete clinical study CABL001J12301 (ASC4FIRST), A Phase 3, Multi-center, Open-label, Randomized Study of Oral Asciminib versus Investigator Selected TKI in Patients with Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase, intended to describe and confirm the clinical benefit of asciminib to include at least 60 months follow-up of all patients.
        1. links
            text
            6/30/2028
          source provenance
          bytes
          102185
          file
          /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
          http status
          200
          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
          19
          source table headers
          1. Drug Name
          2. Accelerated Approval (AA) Indication
          3. AA Date
          4. AA Post-Marketing Requirement
          5. 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
          2024-10-29
          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
            Scemblix (asciminib)
            fda status record id
            fda-aa-f95ec17446197e3c8811
            indication exact
            Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-0b7adb8b1f6b549ba855
            2. ind-span-0cfc6c6af35889d97563
            source provenance
            bytes
            102185
            file
            /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
            http status
            200
            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
            status category
            ongoing
            unmatched meaning
            Source null
            links
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-014078b91952d3a3eeedf0a1
              span id
              ind-span-0cfc6c6af35889d97563
              status id
              fda-aa-f95ec17446197e3c8811
              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
              706
              end exclusive
              true
              exact text
              SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
              label id
              e187165a-eb84-4ee5-98b8-d4e777ec7b4a
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
              start
              517
              fda indication exact
              Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
              fda source row index
              19
              fda source sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              fda status record id
              fda-aa-f95ec17446197e3c8811
              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
              status category
              ongoing
              status event date
              2024-10-29
              supporting anchor spans
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-2fbf1e56c99fe91b55d3c6e8
                span id
                ind-span-0b7adb8b1f6b549ba855
                status id
                fda-aa-f95ec17446197e3c8811
                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
                194
                end exclusive
                true
                exact text
                1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
                label id
                e187165a-eb84-4ee5-98b8-d4e777ec7b4a
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                8668fc711895f8e99a1c39ced71cb5cc89c9a41d1b5e74738c1792a42e0f269e
                start
                0
                fda indication exact
                Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
                fda source row index
                19
                fda source sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                fda status record id
                fda-aa-f95ec17446197e3c8811
                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
                status category
                ongoing
                status event date
                2024-10-29
                supporting anchor spans

                Preserved source evidence · Not medical advice