GO ALL IN WITH PROVEN OUTCOMES

INREBIC® as initial JAK therapy was
studied in a pivotal Phase 3 trial

GO ALL IN WITH PROVEN OUTCOMES

INREBIC® as initial JAK therapy was
studied in a pivotal Phase 3 trial

Efficacy and safety were established in the JAKARTA trial1,2

A Phase 3, randomized, double-blind, placebo-controlled study of 289 patients with intermediate-2 or high-risk primary or secondary MF who were not previously treated with a JAK inhibitor.

  • Primary endpoint was the proportion of patients with ≥35% spleen volume reduction (SVR) from baseline to the end of Cycle 6 as measured by MRI or CT with a scan 4 weeks later
  • Main secondary endpoint was the proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline to the end of Cycle 6 as measured using the MFSAF v2.0 diary

Since the recommended daily dose of INREBIC® is 400 mg, only data from the 400-mg arm will be shown relative to placebo. See below for additional trial details and baseline patient characteristics.

CT, computed tomography; JAK, Janus-associated kinase; MF, myelofibrosis; MFSAF, Myelofibrosis Symptom Assessment Form; MRI, magnetic resonance imaging.

INREBIC® was studied in a robust Phase 3 study (JAKARTA)1,2

Since the recommended daily dose of INREBIC® is 400 mg, only data from the 400-mg arm will be shown
relative to placebo.

JAKARTA was a double-blind, randomized, placebo-controlled study of patients not previously treated with a JAK inhibitor

JAKARTA trial design JAKARTA trial design
Study endpoints1,2

Primary endpointProportion of patients achieving ≥35% SVR from
baseline to the end of Cycle 6, as measured by MRI or
CT with a scan 4 weeks later.

Main secondary endpointProportion of patients ≥50% reduction in TSS from
baseline to the end of Cycle 6, as measured by the
modified MFSAF v2.0 diary.

  • Modified MFSAF included 6 key MF-associated
    symptoms: night sweats, itching, abdominal
    discomfort, early satiety, pain under the ribs on the left
    side, and bone or muscle pain
  • Symptoms were measured on a scale from 0 (absent)
    to 10 (worst imaginable)
Treatment period3

Patients continued to receive INREBIC® if they were:

  • Benefiting from treatment, defined as having had a
    complete or partial remission, clinical improvement, or
    stable disease
  • Not experiencing progressive disease or relapse as
    defined by the modified IWG-MRT criteria, or
    unacceptable toxicity requiring discontinuation of
    INREBIC®

ET, essential thrombocythemia; IWG-MRT, International Working Group–Myeloproliferative Neoplasms Research and Treatment; PV, polycythemia vera.

INREBIC® (400 mg qd) was evaluated in patients with varying MF subtypes,
platelet counts, and risk statuses1,4,5

Overview of patient characteristics at baseline

  INREBIC® (400 mg qd; n=96) PLACEBO (n=96)
Median age, years (range) 63 (39-86) 66 (27-85)
MF SUBTYPE
Primary MF 65% 60%
Post-PV MF 25% 28%
Post-ET MF 10% 12%
PLATELET COUNT
Median 221 × 109/L 187 × 109/L
50 to <100 × 109/L 15% 19%
≥100 × 109/L 85% 81%
IPSS RISK STATUS
Intermediate-2 59% 48%
High risk 41% 52%

IPSS, International Prognostic Scoring System.

INREBIC® delivered powerful spleen responses vs placebo1

Proportion of patients with SVR ≥35% from baseline at the end of Cycle 6*
Spleen response graph: INREBIC® versus placebo Spleen response graph: INREBIC® versus placebo

*Data from the intent-to-treat population, as measured by MRI or CT with a follow-up scan 4 weeks later.

INREBIC® delivered powerful spleen responses vs placebo1

Percent change in spleen volume from baseline at the end of Cycle 6 for each patient†
Per patient spleen response graph: INREBIC® versus placebo Per patient spleen response graph: INREBIC® versus placebo

†Data from patients with available percent changes in spleen volume, as measured by MRI or CT, at the end of Cycle 6.

INREBIC® provided durable spleen responses1

Median duration of spleen response‡
Duration of spleen response graph Duration of spleen response graph

‡Based on Kaplan-Meier estimates.

Spleen responses rates per subgroup for INREBIC® vs placebo6

Limitations of analyses: These analyses are descriptive in nature and offer supportive, but not conclusive, results. These data should be interpreted with caution due to potential selection bias, insufficient sample size, and a higher probability of making a false-positive conclusion.

Subgroup analyses of spleen response rates (SVR ≥35%) at the end of Cycle 6 for the INREBIC® (400 mg qd) arm vs placebo (intent-to-treat population)§
Forest plot of spleen response rates for INREBIC® (400 mg qd) versus placebo Forest plot of spleen response rates for INREBIC® (400 mg qd) versus placebo

ECOG, Eastern Cooperative Oncology Group; ET, essential thrombocythemia; HGB, hemoglobin; LDH, lactate dehydrogenase; PV, polycythemia vera; RBC, red blood cell; ULN, upper limit of normal; WBC, white blood cell.

§Data from the intent-to-treat population, as measured by MRI or CT with a follow-up scan 4 weeks later.
Time from first diagnosis of MF to randomization.

INREBIC® provided significant symptom reduction vs placebo1

Proportion of patients with ≥50% reduction in TSS from baseline at the end of Cycle 6**
Symptom reduction graph: INREBIC® versus placebo Symptom reduction graph: INREBIC® versus placebo

**Data from symptom-evaluable population, as measured using the MFSAF v2.0 diary.

INREBIC® provided significant symptom reduction vs placebo1

Percent change in TSS from baseline at the end of Cycle 6 for each patient††
Per patient symptom reduction graph: INREBIC® versus placebo Per patient symptom reduction graph: INREBIC® versus placebo

††Data from patients with available percent change in TSS at the end of Cycle 6, as measured using the modified MFSAF v2.0 diary.

INREBIC® provided meaningful symptom reduction vs placebo1

Proportion of patients achieving ≥50% reduction in individual symptom scores at the end of Cycle 6‡‡
Per symptom reduction graph: INREBIC® versus placebo Per symptom reduction graph: INREBIC® versus placebo

‡‡Data from patients with nonzero baseline scores, as measured using the modified MFSAF v2.0 diary.

Symptom reduction per cycle for INREBIC® vs placebo7

Proportion of patients achieving a ≥50% reduction in TSS by cycle up to Cycle 6§§
Per cycle symptom reduction graph: INREBIC® versus placebo Per cycle symptom reduction graph: INREBIC® versus placebo

§§Data from patients in the intent-to-treat population with nonmissing baseline TSS. Data for placebo-treated patients in
the study who crossed over to INREBIC® treatment are not counted after the date of crossover.

INREBIC® was also studied in patients previously treated with ruxolitinib8

Limitations: JAKARTA2, a Phase 2, single-arm, open-label study, was prematurely terminated, which impacts the interpretability of the data. No conclusions regarding the benefits or risks of fedratinib in patients who are resistant or intolerant to ruxolitinib can be established based on this study. These data are not included in the US Prescribing Information.

JAKARTA2 was a single-arm, open-label, Phase 2 study of 97 patients with primary or secondary
MF who were resistant or intolerant to ruxolitinib per investigator assessment8,9

  • Primary endpoint was the proportion of patients achieving ≥35% SVR at the end of Cycle 6, as measured by MRI or CT
  • Median exposure to ruxolitinib prior to enrollment in study was 10.7 months
  • Median exposure to INREBIC® during enrollment in study was 24 weeks (range 0.7-79.4 weeks)

Methodology for spleen and symptom assessment8

  • Post hoc analyses of spleen volume (intent-to-treat population) and TSS were performed
  • Only patients who were confirmed responders at the end of Cycle 6 were included; patients missing spleen volume assessments at the end of Cycle 6 were considered nonresponders
Spleen response (intent-to-treat population)8

30.9% of patients (n=30/97) experienced ≥35% SVR at the end of Cycle 6

Symptom response8

26.7% of patients¶¶ (n=24/90) had a ≥50% reduction in TSS at the end of Cycle 6

¶¶Includes patients with an evaluable baseline and ≥1 post-baseline assessment of TSS.

See safety data from JAKARTA2
SAFETY DATA

Adverse reactions with INREBIC® from JAKARTA1

Selected adverse reactions reported in patients in the INREBIC® (400 mg qd) arm

Adverse
reaction*
(≥5% of
patients)		 INREBIC® (400
mg qd; n=96)
All
Grades,
%		 Grade
≥3,† %
PLACEBO (n=95)
All
Grades,
%		 Grade
≥3, %
Diarrhea 66 5 16 0
Nausea 62 0 15 0
Anemia 40 30 14 7
Vomiting 39 3.1 5 0
Fatigue or asthenia 19 5 16 1.1
Muscle spasms 12 0 1.1 0
Blood creatinine increased 10 1 1.1 0
Pain in extremity 10 0 4.2 0
ALT increased 9 0 1.1 0
Headache 9 0 1.1 0
Weight increased 9 0 4.2 0
Dizziness 8 0 3.2 0
Bone pain 8 0 2.1 0
Urinary tract infection‡ 6 0 1.1 0
Dysuria 6 0 0 0
AST increased 5 0 1.1 0

ALT, alanine aminotransferase; AST, aspartate aminotransferase. *Based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
†Only 1 Grade 4 event (anemia).
‡Includes cystitis.

Serious adverse reactions occurred in 21% of patients receiving INREBIC®.
  • Those that occurred in ≥2% of patients included cardiac failure (5%) and anemia (2%)
  • Fatal adverse reactions of cardiogenic shock occurred in 1% of patients

Selected laboratory abnormalities that have worsened from baseline (≥20%) in patients in the
INREBIC® (400 mg qd) arm§

Laboratory parameter INREBIC® (400 mg qd; n=96)
All
Grades,
%		 Grade
≥3, %
PLACEBO (n=95)
All
Grades,
%		 Grade
≥3, %
HEMATOLOGY
Anemia 74 34 32 10
Thrombocytope
nia		 47 12 26 10
Neutropenia 23 5 13 3.3
BIOCHEMISTRY
Creatinine increased 59 3.1 19 1.1
ALT increased 43 1 14 0
AST increased 40 0 16 1.1
Lipase increased 35 10 7 2.2
Hyponatremia 26 5 11 4.3
Amylase increased 24 2.1 5 0

§With a difference between arms of >10% when compared to placebo during randomized treatment.

Adverse reactions with INREBIC® from JAKARTA2, which studied patients previously treated with ruxolitinib10

Limitations: JAKARTA2, a Phase 2, single-arm, open-label study, was prematurely terminated, which impacts the interpretability of the data. No conclusions regarding the benefits or risks of fedratinib in patients who are resistant or intolerant to ruxolitinib can be established based on this study. These data are not included in the US Prescribing Information.

Hematologic adverse reactions (intent-to-treat population)

Laboratory parameter INREBIC® (400 mg qd; N=97)
All Grades, % Grade 3, % Grade 4, %
Anemia 99.0 46.4 0
Thrombocytopenia 70.1 16.5 7.2
Neutrophil count decreased 24.0 5.2 2.1

Presented values are worst-grade values regardless of baseline.

Nonhematologic adverse reactions (intent-to-treat population)

Adverse reaction INREBIC® (400 mg qd; N=97)
All Grades, % Grade 3, % Grade 4, %
GASTROINTESTINAL ADVERSE REACTIONS IN ≥10% OF PATIENTS
Diarrhea 61.9 4.1 0
Nausea 55.7 0 0
Vomiting 41.2 0 0
Constipation 20.6 1.0 0
OTHER NONHEMATOLOGIC ADVERSE REACTIONS IN ≥10% OF PATIENTS
Fatigue 15.5 2.1 0
Headache 13.4 1.0 0
Urinary tract infection** 12.4 0 0
Asthenia 11.3 1.0 0
Dizziness 11.3 0 0
BIOCHEMISTRY††
Creatinine increased 74.2 0 0
AST increased 47.4 1.0 0
ALT increased 45.4 2.1 0
Lipase increased 25.8 7.2 1.0
Amylase increased‡‡ 17.7 3.1 0

ALT, alanine aminotransferase; AST, aspartate aminotransferase. **Includes cystitis.
††Presented values are worst-grade values regardless of baseline.
‡‡Of 96 evaluable patients.

Encephalopathy, including Wernicke’s encephalopathy (WE), in the INREBIC® clinical development program1

Encephalopathy is a neurologic emergency that can be fatal.

  • In the clinical development program of INREBIC®, which included 608 patients, serious and fatal cases of
    encephalopathy, including WE, occurred in patients receiving INREBIC®
  • Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC® in clinical trials and 0.16%
    (1/608) of cases were fatal
  • WE is attributable to thiamine (vitamin B1) deficiency. While on INREBIC, all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated
  • Signs and symptoms of WE may include ataxia, mental status changes, and ophthalmoplegia (eg, nystagmus, diplopia)
  • Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including WE, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging
Guidance on how to manage encephalopathy

Safety information for adverse reactions that may require dose
adjustments of INREBIC®1

Hematologic
  • Median time to the first onset of Grade 3 anemia was approximately
    2 months - 75% of cases occurred within 3 months
  • Median time to the first onset of Grade 3 thrombocytopenia was
    approximately 1 month - 75% of cases occurred within 4 months
  • Thrombocytopenia-related dose reductions (2%) and
    discontinuations (2%), as well as anemia-related dose reductions
    (6%) and discontinuations (1%), occurred with INREBIC®
  • 51% of patients treated with INREBIC® received red blood cell
    transfusions; 3.1% of patients treated with INREBIC® received
    platelet transfusions
Gastrointestinal
  • Median time to onset of any grade nausea, vomiting, and diarrhea
    was 1 day - 75% of cases occurring within 2 weeks of treatment
Transaminase
  • Median time to onset of any grade transaminase elevation was
    approximately 1 month - 75% of cases occurring within 3 months
Amylase and lipase elevation
  • Median time to onset of any grade amylase or lipase elevation was 15 days - 75% of cases occurring within 1 month
Recommended dose
modifications for INREBIC®
GETTING STARTED ON
INREBIC®

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IMPORTANT SAFETY INFORMATION

WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S
Serious and fatal encephalopathy, including Wernicke’s, has occurred in patients treated with INREBIC. Wernicke’s encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

WARNINGS AND PRECAUTIONS

Encephalopathy, including Wernicke’s: Serious and fatal encephalopathy, including Wernicke’s encephalopathy, has occurred in INREBIC-treated patients. Serious cases were reported in 1.3% (8/608) of patients treated with INREBIC in clinical trials and 0.16% (1/608) of cases were fatal. Wernicke’s encephalopathy is a neurologic emergency resulting from thiamine (Vitamin B1) deficiency. Signs and symptoms of Wernicke’s encephalopathy may include ataxia, mental status changes, and ophthalmoplegia (e.g., nystagmus, diplopia). Any change in mental status, confusion, or memory impairment should raise concern for potential encephalopathy, including Wernicke’s, and prompt a full evaluation including a neurologic examination, assessment of thiamine levels, and imaging. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency. However, if thiamine levels are low, replete thiamine prior to starting treatment. While on treatment all patients should receive prophylaxis with oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.

Anemia: New or worsening Grade 3 anemia occurred in 34% of INREBIC-treated patients. The median time to onset of the first Grade 3 anemia was approximately 2 months, with 75% of cases occurring within 3 months. Mean hemoglobin levels reached a nadir after 12 to 16 weeks with partial recovery and stabilization after 16 weeks. Red blood cell transfusions were received by 51% of INREBIC-treated patients and permanent discontinuation of INREBIC due to anemia occurred in 1% of patients. Consider dose reduction for patients who become red blood cell transfusion dependent.

Thrombocytopenia: New or worsening Grade 3 or higher thrombocytopenia during the randomized treatment period occurred in 12% of INREBIC-treated patients. The median time to onset of the first Grade 3 thrombocytopenia was approximately 1 month, with 75% of cases occurring within 4 months. Platelet transfusions were received by 3.1% of INREBIC-treated patients. Permanent discontinuation of treatment due to thrombocytopenia and bleeding that required clinical intervention both occurred in 2.1% of INREBIC-treated patients. Obtain a complete blood count (CBC) at baseline, periodically during treatment, and as clinically indicated. For Grade 3 thrombocytopenia with active bleeding or Grade 4 thrombocytopenia, interrupt INREBIC until resolved to Grade 2 or lower or to baseline. Restart dose at 100 mg daily below the last given dose and monitor platelets as clinically indicated.

Gastrointestinal Toxicity: Gastrointestinal toxicities are the most frequent adverse reactions in INREBIC-treated patients. During the randomized treatment period, diarrhea occurred in 66% of patients, nausea in 62% of patients, and vomiting in 39% of patients. Grade 3 diarrhea occurred in 5% and Grade 3 vomiting in 3.1%. The median time to onset of any grade nausea, vomiting, and diarrhea was 1 day, with 75% of cases occurring within 2 weeks of treatment. Consider providing appropriate prophylactic antiemetic therapy (e.g., 5-HT3 receptor antagonists) during INREBIC treatment. Treat diarrhea with antidiarrheal medications promptly at the first onset of symptoms. For Grade 3 or higher nausea, vomiting, or diarrhea not responsive to supportive measures within 48 hours, interrupt INREBIC until resolved to Grade 1 or lower or to baseline. Restart dose at 100 mg daily below the last given dose. Monitor thiamine levels and replete as needed.

Hepatic Toxicity: Elevations of ALT and AST (all grades) during the randomized treatment period occurred in 43% and 40%, respectively, with Grade 3 or 4 in 1% and 0%, respectively, of INREBIC-treated patients. The median time to onset of any grade transaminase elevation was approximately 1 month, with 75% of cases occurring within 3 months. Monitor hepatic function at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher ALT and/or AST elevations (greater than 5 × ULN), interrupt INREBIC dose until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose. If reoccurrence of a Grade 3 or higher elevation of ALT/AST, discontinue treatment with INREBIC.

Amylase and Lipase Elevation: Grade 3 or higher amylase and/or lipase elevations developed in 2% and 10% of INREBIC-treated patients, respectively. The median time to onset of any grade amylase or lipase elevation was 15 days, with 75% of cases occurring within 1 month of starting treatment. One patient developed pancreatitis in the fedratinib clinical development program (n=608) and pancreatitis resolved with treatment discontinuation. Monitor amylase and lipase at baseline, periodically during treatment, and as clinically indicated. For Grade 3 or higher amylase and/or lipase elevations, interrupt INREBIC until resolved to Grade 1 or less or to baseline. Restart dose at 100 mg daily below the last given dose.

Major Adverse Cardiac Events (MACE): Another JAK inhibitor has increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. Consider the benefits and risks of the individual patients prior to initiating or continuing therapy with INREBIC, particularly in patients who are current or past smokers, or have other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and what to do if they occur.

Thrombosis: Another JAK inhibitor has increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis in patients with rheumatoid arthritis (compared to those treated with TNF blockers), a condition for which INREBIC is not indicated. In patients with MF treated with INREBIC in clinical trials, the rates of thromboembolic events were similar in INREBIC and placebo treated patients. Promptly evaluate and treat patients with symptoms of thrombosis.

Secondary Malignancies: Another JAK inhibitor has increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which INREBIC is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with INREBIC, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

ADVERSE REACTIONS

The most common adverse reactions for INREBIC treated vs. placebo were diarrhea (66% vs. 16%), nausea (62% vs. 15%), anemia (40% vs. 14%), and vomiting (39% vs. 5%). Dosage interruptions due to an adverse reaction during the randomized treatment period occurred in 21% of patients who received INREBIC. Adverse reactions requiring dosage interruption in >3% of patients who received INREBIC included diarrhea and nausea. Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC. Adverse reactions requiring dosage reduction in >2% of patients who received INREBIC included anemia (6%), diarrhea (3%), vomiting (3%), and thrombocytopenia (2%).

DRUG INTERACTIONS

Coadministration of INREBIC with a strong CYP3A4 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Consider alternative therapies that do not strongly inhibit CYP3A4 activity. Alternatively, reduce the dose of INREBIC when administering with a strong CYP3A4 inhibitor. Avoid INREBIC with strong and moderate CYP3A4 inducers. Coadministration of INREBIC with a dual CYP3A4 and CYP2C19 inhibitor increases fedratinib exposure. Increased exposure may increase the risk of adverse reactions. Due to potential increase of exposure, patients taking concomitant dual CYP3A4 and CYP2C19 inhibitors require more intensive safety monitoring and, if necessary, dose modifications of INREBIC based on adverse reactions. Coadministration of INREBIC with drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates increases the concentrations of these drugs, which may increase the risk of adverse reactions of these drugs. Monitor for adverse reactions and adjust the dose of drugs that are CYP3A4, CYP2C19, or CYP2D6 substrates as necessary when coadministered with INREBIC. Coadministration of INREBIC with drugs that are renally excreted via organic cation transporter (OCT2) and multidrug and toxin extrusion (MATE)1/2-K can decrease renal clearance of those drugs. Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin) as necessary when coadministered with INREBIC.

PREGNANCY/LACTATION

Consider the benefits and risks of INREBIC for the mother and possible risks to the fetus when prescribing INREBIC to a pregnant woman. Due to the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with INREBIC, and for at least 1 month after the last dose.

RENAL IMPAIRMENT

Reduce INREBIC dose when administered to patients with severe renal impairment. No modification of the starting dose is recommended for patients with mild to moderate renal impairment. Due to potential increase of exposure, patients with preexisting moderate renal impairment require more intensive safety monitoring, and if necessary, dose modifications based on adverse reactions.

Please see full Prescribing Information, including Boxed WARNING.

INDICATION

INREBIC® (fedratinib) is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

Information for Vermont prescribers of prescription drugs
References
  1. INREBIC® [package insert]. Summit, NJ: Celgene Corporation; 2024.
  2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 9, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.
  3. Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. JAMA Oncol. 2015;1:643-651.
  4. Protocol for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. JAMA Oncol. 2015. doi:10.1001/jamaoncol.2015.1590.
  5. Supplemental content for: Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. JAMA Oncol. 2015. doi:10.1001/jamaoncol.2015.1590.
  6. Harrison C, Schaap N, Vannucchi AM, et al. Fedratinib induces spleen responses and reduces symptom burden in patients with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF) and low platelet counts, who were ruxolitinib-naïve or previously treated with ruxolitinib. Poster presented at the 61st Annual Meeting of the American Society of Hematology (ASH); December 7-9, 2019; Orlando, FL.
  7. Data on file. FED-0005. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  8. Data on file. FED-0006. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  9. Harrison CN, Schaap N, Vannucchi AM, et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: an updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. Am J Hematol. 2020;95:594-603.
  10. Data on file. FED-0008. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  11. Data on file. FED-0009. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  12. Data on file. FED-0007. Princeton, NJ; Bristol-Myers Squibb Company; 2022.
  13. Data on file. FED-0004. Princeton, NJ; Bristol-Myers Squibb Company; 2022.

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