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Subject:
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Durable remission is possible for patients with R/R mIDH1 AML |
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R/R mIDH1 AML: durable remission from a targeted option |
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Is durable remission possible in R/R mIDH1 AML? |
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Preheader:
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See the long-term data |
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See the response rates and duration |
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Transform your expectations |
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Developed under the direction and sponsorship of Rigel Pharmaceuticals, Inc.
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TRANSFORM YOUR EXPECTATIONS
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TRANSFORM YOUR EXPECTATIONS
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for adult patients with relapsed/refactory mIDH1 AML
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for adult patients with relapsed/refactory mIDH1 AML
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DURABLE REMISSION IS POSSIBLE
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DURABLE REMISSION IS POSSIBLE
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REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory
acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1)
mutation as detected by an FDA-approved test.
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SELECT IMPORTANT SAFETY INFORMATION
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WARNING: DIFFERENTIATION SYNDROME
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Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/ pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain.
If differentiation syndrome is suspected, withhold REZLIDHIA and initiate
treatment with corticosteroids and hemodynamic monitoring until symptom
resolution.
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REZLIDHIA CLINICAL SUMMARY*
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Almost half of patients achieved
a composite complete remission1-3
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35% CR/CRh
32% CR
45% CRc
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Over 2-year duration of response3
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25.3 months median duration of CR/CRh
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High-risk subgroups
saw results consistent
with overall population2-7
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Post-venetoclax: 50% CRc
Post-intensive
chemotherapy†: 46% CRc
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Median time to
response was less
than 2 months3
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88% of responders
achieved CR/CRh
within 4 months
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Well-characterized safety profile1,3
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Long-term use revealed no new safety signals
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*
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Data from an open-label, single-arm, multicenter clinical trial of 153 adult patients
(147 efficacy evaluable) with relapsed or refractory AML with an IDH1
mutation. All response data is tied to a June 15, 2023 data cutoff. The safety profile uses a June 18, 2021 data cutoff.
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†
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Intensive chemotherapy was the only prior regimen these patients received. Intensive chemotherapy was defined as high-dose cytarabine with daunorubicin, mitoxantrone with etoposide and cytarabine, or transplant conditioning regimens, whether myeloablative or not.
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For patients with mIDH1 AML who relapse
or are refractory to
initial treatment, choose
REZLIDHIA as the first R/R targeted therapy
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CR=complete remission; CRc=composite complete remission (CR+CRh+CRi); CRh=CR with partial hematologic recovery; CRi=complete remission with incomplete blood count recovery; mIDH1=mutated isocitrate dehydrogenase-1; R/R=relapsed or refractory.
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SUPPORT IS AVAILABLE FOR YOU AND YOUR
PATIENTS THROUGH RIGEL ONECARE®
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IMPORTANT SAFETY INFORMATION (CONT'D)
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REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in
patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of
patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients
treated, and fatalities in 1% of patients. Differentiation syndrome is associated with
rapid proliferation and differentiation of myeloid cells and may be life-threatening or
fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included
leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury,
fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced
differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption
of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months
after REZLIDHIA initiation and has been observed with or without concomitant
leukocytosis.
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If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate
systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of
3 days and until resolution of signs and symptoms. If concomitant leukocytosis is
observed, initiate treatment with hydroxyurea, as clinically indicated. Taper
corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome
may recur with premature discontinuation of corticosteroids and/or hydroxyurea
treatment. Institute supportive measures and hemodynamic monitoring until improvement;
withhold dose of REZLIDHIA and consider dose reduction based on recurrence.
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REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase
(ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase,
and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received
REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4
hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in
the clinical trial, a combination for which REZLIDHIA is not indicated, died from
complications of drug-induced liver injury. The median time to onset of hepatotoxicity
in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months
(range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to
resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities
were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.
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Monitor patients frequently for clinical symptoms of hepatic dysfunction such as
fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain
baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for
the first two months, once every other week for the third month, once in the fourth
month, and once every other month for the duration of therapy. If hepatic dysfunction
occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on
recurrence/severity.
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The most common (≥20%) adverse reactions, including laboratory abnormalities, were
aspartate aminotransferase increased, alanine aminotransferase increased, potassium
decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine
increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin
increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased,
mucositis, diarrhea and transaminitis.
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Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
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Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise
instructed in the substrates prescribing information. If concomitant use is unavoidable,
monitor patients for loss of therapeutic effect of these drugs.
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Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the
last dose.
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No overall differences in effectiveness were observed between patients 65 years and
older and younger patients. Compared to patients younger than 65 years of age, an
increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65
years of age.
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In patients with mild or moderate hepatic impairment, closely monitor for increased
probability of differentiation syndrome.
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REFERENCES: 1. REZLIDHIA®. Package insert. Rigel Pharmaceuticals, Inc; 2022.
2. de Botton S, Fenaux P, Yee K, et al. Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML. Blood Adv. 2023:7(13):3117-3127. doi:10.1182/bloodadvances.2022009411
3. Cortes J, Curti A, Fenaux P, et al. Olutasidenib for mutated IDH1 acute myeloid leukemia: final five-year results from the phase 2 pivotal cohort. J Hematol Oncol. 2025;18(1):102. doi:10.1186/s13045-025-01751-w
4. Data on file, Rigel Pharmaceuticals, Inc. January 2025.
5. Cortes J, Curti A, Fenaux P, et al. Olutasidenib for mutated IDH1 acute myeloid leukemia: final five-year results from the phase 2 pivotal cohort (supplemental data). J Hematol Oncol. 2025; https://link.springer.com/article/10.1186/s13045-025-01751-w#Sec20
6. Maiti A, Rausch CR, Cortes JE, et al. Outcomes of relapsed or refractory acute myeloid leukemia after frontline hypomethylating agent and venetoclax regimens. Haematologica. 2021;106(3):894-898. doi:10.3324/haematol.2020.252569
7. Niscola P, Gianfelici V, Catalano G, et al. Acute myeloid leukemia in older patients: from new biological insights to targeted therapies. Curr Oncol. 2024;31(11):6632-6658. Error in Figure 1 legend. Correction. Curr Oncol. 2025;32(7):386. doi:10.3390/curroncol32070386
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© 2026 Rigel Pharmaceuticals, Inc. All rights reserved. REZ_AML-25090 0226
REZLIDHIA and RIGEL ONECARE are registered trademarks of Rigel Pharmaceuticals, Inc.
RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc.
611 Gateway Blvd, Suite 900, South San Francisco, CA 94080
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