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• Remission may be possible for R/R mIDH1 AML
• Durable response data for R/R mIDH1 AML patients
• For R/R mIDH1 AML, remission may be possible
REZLIDHIA® (olutasidenib)
 
DURABLE REMISSION
IS POSSIBLE
Rezlidhia provided a clinically
meainingful response with durable, complete remission
Rezlidhia provided a clinically meainingful response with durable, complete remission
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  • I hope all is well. I have some detailed efficacy data for REZLIDHIA that I think you’ll find interesting.
  • As your rep for REZLIDHIA, I’d like to share some interesting data that could benefit your patients living with relapsed or refractory mIDH1 AML.
  • I hope you’re doing well. I wanted to follow up on our previous conversation and share some efficacy and safety data for REZLIDHIA.
  • I wanted to share efficacy data for REZLIDHIA that could transform your expectations for treatment for relapsed or refractory mIDH1 AML.

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.

Almost half of patients achieved a composite complete remission
Almost half of patients achieved a composite complete remission

Clinical Response Rates1-3

Data cutoff=June 15, 2023.
Additional Efficacy Outcomes1-4
  • Response rates were similar regardless of prior treatment with venetoclax or intensive chemotherapy
  • Median time to CR/CRh was 1.9 months (95% CI: 1-2.8)
  • 11% (16 of 147) of patients underwent stem cell transplant after treatment with REZLIDHIA


The majority of responders achieved
COMPLETE REMISSION2


CI=confidence interval; CR=complete remission; CRc=composite complete remission (CR+CRh+CRi); CRh=CR with partial hematologic recovery; CRi=CR with incomplete blood count recovery; MLFS=morphologic leukemia–free state; PR=partial remission (which required recovery of both neutrophil and platelet counts consistent with a CR).
MEDIAN DURATION OF RESPONSE IN PATIENTS ACHIEVING CR/CRh WAS GREATER THAN 2 YEARS
MEDIAN DURATION OF RESPONSE IN PATIENTS ACHIEVING CR/CRh WAS GREATER THAN 2 YEARS

Duration of CR/CRh Response3

DOR=duration of response.
* 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.1


25.3 MONTHS
(95% CI: 13.5-NR)
Median duration of CR/CRh3




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


NR=not reached; R/R=relapsed or refractory.

Here is some additional information that you may find useful.

Clinical Publication: Olutasidenib (FT-2102) induces durable complete remissions in patients with relapsed or refractory IDH1-mutated AML

Review the results of the REZLIDHIA clinical trial in Blood Advances for details about efficacy, safety, and more.

Clinical Publication: Olutasidenib for Mutated IDH1 Acute Myeloid Leukemia: Final Five-Year Results From the Phase 2 Pivotal Cohort

Learn about the final 5-year efficacy and safety results from the REZLIDHIA pivotal cohort in the Journal of Hematology & Oncology.

RIGEL ONECARE®

Find support for every step of treatment, including how to access REZLIDHIA, copay assistance, patient support services, and downloadable resources for you and your patients.

Download the REZLIDHIA Patient Education Guide

Important information for patients about what to expect with REZLIDHIA when starting treatment.

Download the REZLIDHIA Dosing Guide

Information on REZLIDHIA dosing and administration, monitoring, and dose modifications to manage potential adverse reactions.

Download the Distribution Guide

Find information on REZLIDHIA distribution and pharmacy networks, and patient support services.

Download the Enrollment Form

Enroll patients in RIGEL ONECARE® for patient support services including benefits verification, prior authorizations, temporary and long-term drug supply, and adherence support. All Rigel programs are subject to eligibility requirements. Restrictions may apply.

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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 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. 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.202200941 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.

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