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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Imbruvica (ibrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Health Canada Authorizes IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination with Venetoclax for Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Published date:
03/23/2023
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance (NOC) authorizing the expanded use of IMBRUVICA® (ibrutinib) in a first all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukemia (CLL), including those with 17p deletion (del 17p). This authorization is based on the pivotal Phase 3 GLOW study...
Source:
Title:
European Commission Approves IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
Published date:
08/04/2022
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA® (ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL). The approval is based on the pivotal Phase 3 GLOW study that demonstrated superior progression-free survival (PFS) in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O)...
Source:
Published date:
08/30/2022
Excerpt:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma...SUGGESTED TREATMENT REGIMENS...CLL/SLL without del(17p)/TP53 mutation…Other recommended regimens…Ibrutinib + venetoclax…
Source:
Title:
Fixed-duration ibrutinib-venetoclax versus chlorambucil-obinutuzumab in previously untreated chronic lymphocytic leukaemia (GLOW): 4-year follow-up from a multicentre, open-label, randomised, phase 3 trial
Published date:
11/06/2023
Excerpt:
After 4 years of follow-up, ibrutinib-venetoclax continues to significantly prolong progression-free survival (vs chemoimmunotherapy) in patients with previously untreated chronic lymphocytic leukaemia, supporting its use as a first-line option.
DOI:
10.1016/S1470-2045(23)00452-7
Trial ID:
Source:
Title:
Janssen Receives Positive CHMP Opinion for IMBRUVICA® (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
Published date:
06/24/2022
Excerpt:
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of a new treatment option with IMBRUVICA® (ibrutinib) in an oral fixed-duration combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL)....The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the efficacy and safety of ibrutinib plus venetoclax in patients with previously untreated CLL.
