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•	Clinical need: Efficacy after a venetoclax-based regimen
•	Results after a venetoclax-based treatment in R/R mIDH1 AML
•	Outcomes in patients with mIDH1 AML post-venetoclax
•	R/R AML: See efficacy results after venetoclax-based regimens

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Developed under the direction and sponsorship of Rigel Pharmaceuticals, Inc.

Important Safety Information Full Prescribing Information Medication Guide

AFTER A VENETOCLAX-BASED REGIMEN,
PATIENTS WITH AML MAY EXPERIENCE
POOR OUTCOMES

•	Virtually all patients with acute myeloid leukemia (AML) eventually relapse, become intolerant, or become resistant to a venetoclax-based treatment, even after a favorable initial result^1-8
•	Outcomes for patients after venetoclax-based regimens are often dismal^1-8

Virtually all patients with acute myeloid leukemia (AML) eventually relapse, become intolerant, or become resistant to a venetoclax-based treatment, even after a favorable initial result^1-8
Outcomes for patients after venetoclax-based regimens are often dismal^1-8

Effective treatment after a venetoclax-based regimen
is an area of urgent unmet clinical need.^1-3,5-8

DURABLE REMISSION
IS POSSIBLE

REZLIDHIA PROVIDED A CLINICALLY
MEANINGFUL RESPONSE WITH DURABLE, COMPLETE REMISSION

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.

SELECT IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

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.

Please see additional Important Safety Information below and Full Prescribing Information, including Boxed WARNING.

View the efficacy of REZLIDHIA from the pivotal trial and long-term analysis.

	Data cutoff=June 15, 2023.
*	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.
^†	Primary endpoint.
	CI=confidence interval; CR=complete remission; CRc=composite complete remission (CR+CRh+CRi); CRh=complete remission with partial hematologic recovery; CRi=complete remission with incomplete blood count recovery; NR=not reached; R/R=relapsed or refractory.

PATIENTS TREATED WITH VENETOCLAX IN THE PIVOTAL TRIAL HAD
RESPONSES THAT WERE CONSISTENT WITH THE
OVERALL POPULATION

Findings from a subgroup analysis of 12 patients treated with a venetoclax-based regimen prior to treatment with REZLIDHIA.^10,11

Clinical Response Rates (n=12)¹³

Median time to CR/CRh was 2.35 months (range: 1-2.8 months)¹¹
Median duration of previous venetoclax-based treatment was 6.7 months (range: 2-34 months)¹¹

“The results presented for the pivotal cohort of this phase 2 study suggest that olutasidenib treatment may show clinical benefit across a broad range of patients with R/R mIDH1 AML, including those refractory to multiple prior therapies, including venetoclax-based regimens."

—Cortes et al. J Hematol Oncol. 2025.¹¹

For patients with mIDH1 AML who relapse or are refractory to initial treatment, choose REZLIDHIA as the first R/R targeted therapy.

Results from the subgroup analysis

SUPPORT IS AVAILABLE FOR YOU AND YOUR
PATIENTS THROUGH RIGEL ONECARE

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IMPORTANT SAFETY INFORMATION (CONT'D)

WARNINGS AND PRECAUTIONS

Differentiation Syndrome

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.

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.

Hepatotoxicity

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.

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.

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

•	Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.	Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
•	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.	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.

LACTATION

Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.

GERIATRIC USE

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.

HEPATIC IMPAIRMENT

In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.

Please see REZLIDHIAhcp.com for Full Prescribing Information, including Boxed WARNING.

REFERENCES: 1. Bewersdorf JP, Shallis RM, Derkach A, et al. Efficacy of FLT3 and IDH1/2 inhibitors in patients with acute myeloid leukemia previously treated with venetoclax. Leuk Res. 2022;122:106942. doi:10.1016/j.leukres.2022.106942 2. Abaza Y, Winer ES, Murthy GSG, et al. Clinical outcomes of hypomethylating agents plus venetoclax as frontline treatment in patients 75 years and older with acute myeloid leukemia: real-world data from eight US academic centers. Am J Hematol. Published online February 11, 2024. doi:10.1002/ajh.27231 3. Thol F, Döhner H, Ganser A. How I treat refractory and relapsed acute myeloid leukemia. Blood. 2024;143(1):11-20. doi:10.1182/blood.2023022481 4. Gangat N, Ilyas R, Johnson IM, et al. Outcome of patients with acute myeloid leukemia following failure of frontline venetoclax plus hypomethylating agent therapy. Haematologica. 2023;108(11):3170-3174. doi:10.3324/haematol.2022.282677 5. Khanna V, Azenkot T, Liu SQ, et al. Outcomes with molecularly targeted agents as salvage therapy following frontline venetoclax + hypomethylating agent in adults with acute myeloid leukemia: a multicenter retrospective analysis. Leuk Res. 2023;131:107331. doi:10.1016/j.leukres.2023.107331 6. Maiti A, Qiao W, Sasaki K, et al. Venetoclax with decitabine vs intensive chemotherapy in acute myeloid leukemia: a propensity score matched analysis stratified by risk of treatment-related mortality. Am J Hematol. 2021;96(3):282-291. doi:10.1002/ajh.26061 7. Tenold ME, Moskoff BN, Benjamin DJ, et al. Outcomes of adults with relapsed/refractory acute myeloid leukemia treated with venetoclax plus hypomethylating agents at a comprehensive cancer center. Front Oncol. 2021;11:649209. doi:10.3389/fonc.2021.649209 8. Cortes J, Jonas BA, Schiller G, et al. Olutasidenib in post-venetoclax patients with mutant isocitrate dehydrogenase 1 (mIDH1) acute myeloid leukemia (AML). Leuk Lymphoma. Published online March 27, 2024. doi:10.1080/10428194.2024.2333451 9. REZLIDHIA^®. Package insert. Rigel Pharmaceuticals, Inc; 2022. 10. 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 11. 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 12. Data on file, Rigel Pharmaceuticals, Inc. January 2025. 13. 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

© 2026 Rigel Pharmaceuticals, Inc. All rights reserved. REZ_AML-25092 0226
REZLIDHIA and RIGEL ONECARE are registered trademarks of Rigel Pharmaceuticals, Inc.
RIGEL ONECARE is a patient support center sponsored by Rigel Pharmaceuticals, Inc.
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