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IDHIFA (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 mutation as detected by an FDA-approved test.
 
 
WARNING: DIFFERENTIATION SYNDROME
 
Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
 
 
Please see additional Important Safety Information below and full Prescribing Information, including Boxed WARNING.
 
 
Approval of IDHIFA was based on results from a
 
CLINICAL TRIAL OF 199 ADULT PATIENTS WITH R/R AML AND AN IDH2 MUTATION
 
Dear Amy,
 
By targeting IDH2, IDHIFA offers a new approach for patients with relapsed or refractory (R/R) AML. See below for key efficacy data.
 
 
IDHIFA was evaluated in an open-label, single-arm, multicenter, 2 cohort clinical trial of 199 adult patients with R/R AML and an IDH2 mutation. IDHIFA was given orally at a starting dose of 100 mg daily until disease progression or unacceptable toxicity. Dose reductions were allowed to manage side effects. Patients had a median age of 68 years (range, 19 to 100) and received a median of 2 prior anticancer regimens (range, 1 to 6). More than half (52%) were refractory to previous therapy.
 
Efficacy was established on the basis of the rate of complete response (CR)/complete response with partial hematologic recovery (CRh), the duration of CR/CRh, and the rate of conversion from transfusion dependence to transfusion independence
   
The median follow-up was 6.6 months (range, 0.4 to 27.7)
 
IDHIFA EFFICACY OUTCOMES
 
EFFICACY RESULTS IN PATIENTS WITH R/R AML (N=199)
 
  CRa CRhb CR/CRh
n (%) 37 (19%)
(95% CI, 13%-25%)
9 (4%)
(95% CI, 2%-8%)
46 (23%)
(95% CI, 18%-30%)
Media DORc (months) 8.2
(95% CI, 4.7-19.4)
9.6
(95% CI, 0.7-NA)
8.2
(95% CI, 4.3-19.4)
 
a CR was defined as <5% of blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets >100,000/µL and ANC >1,000/µL).
b CRh was defined as <5% of blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/µL and ANC >500/µL).
c DOR was defined as time since first response of CR or CRh to relapse or death, whichever is earlier.
ANC, absolute neutrophil count; CI, confidence interval; DOR, duration of response; NA, not available.
 
RESPONSE TIMES
 
MEDIAN TIME TO FIRST AND BEST RESPONSE
 
  Time to first response
(months)
Time to best response of CR/CRh
(months)
Patients achieving CR/CRh
(n=46/199)
1.9
(range, 0.5-7.5)
3.7
(range, 0.6-11.2)
 
 
Red blood cell (RBC)- and platelet-transfusion independence
 
Among the 157 patients who were dependent on RBC and/or platelet transfusions at baseline, 53 (34%) became independent of RBC and platelet transfusions during any 56-day post-baseline period.
 
Of the 42 patients who were independent of both RBC and platelet transfusions at baseline, 32 (76%) remained transfusion independent during any 56-day post-baseline period.
 
IDHIFA SAFETY EVALUATION
 
The safety evaluation of single-agent IDHIFA is based on 214 patients with R/R AML who were assigned to receive 100 mg daily.
 
The median duration of exposure to IDHIFA was 4.3 months (range, 0.3 to 23.6)
   
The 30-day and 60-day mortality rates observed with IDHIFA were 4.2% (9/214) and 11.7% (25/214), respectively
 
ADVERSE REACTIONS
 
The most common adverse reactions (≥20%) included total bilirubin increased (81%), calcium decreased (74%), nausea (50%), diarrhea (43%), potassium decreased (41%), vomiting (34%), decreased appetite (34%), and phosphorus decreased (27%)
   
The most frequently reported ≥Grade 3 adverse reactions (≥5%) included total bilirubin increased (15%), potassium decreased (15%), phosphorus decreased (8%), calcium decreased (8%), diarrhea (8%), differentiation syndrome (7%), non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and nausea (5%)
   
Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure
 
LEARN MORE FROM A CELGENE HEMATOLOGY/ONCOLOGY CONSULTANT
 
 
IMPORTANT SAFETY INFORMATION
 
 
WARNING: DIFFERENTIATION SYNDROME
 
Patients treated with IDHIFA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, lymphadenopathy, bone pain, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.
 
 
WARNINGS AND PRECAUTIONS
 
Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. Differentiation syndrome has been observed with and without concomitant hyperleukocytosis, as early as 10 days and at up to 5 months after IDHIFA initiation. Symptoms in patients treated with IDHIFA included acute respiratory distress represented by dyspnea and/or hypoxia and need for supplemental oxygen; pulmonary infiltrates and pleural effusion; renal impairment; fever; lymphadenopathy; bone pain; peripheral edema with rapid weight gain; and pericardial effusion. Hepatic, renal, and multi-organ dysfunction have also been observed. If differentiation syndrome is suspected, initiate systemic corticosteroids and hemodynamic monitoring until improvement. Taper corticosteroids only after resolution of symptoms. Differentiation syndrome symptoms may recur with premature discontinuation of corticosteroids. If severe pulmonary symptoms requiring intubation or ventilator support and/or renal dysfunction persist for more than 48 hours after initiation of corticosteroids, interrupt IDHIFA until signs and symptoms are no longer severe. Hospitalization for close observation and monitoring of patients with pulmonary and/or renal manifestation is recommended.
 
Embryo-Fetal Toxicity: Based on animal embryo-fetal toxicity studies, IDHIFA can cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with IDHIFA and for at least 1 month after the last dose. Pregnant women, patients becoming pregnant while receiving IDHIFA, or male patients with pregnant female partners should be apprised of the potential risk to the fetus.
 
ADVERSE REACTIONS
 
The most common adverse reactions (≥20%) included total bilirubin increased (81%), calcium decreased (74%), nausea (50%), diarrhea (43%), potassium decreased (41%), vomiting (34%), decreased appetite (34%), and phosphorus decreased (27%)
   
The most frequently reported ≥Grade 3 adverse reactions (≥5%) included total bilirubin increased (15%), potassium decreased (15%), phosphorus decreased (8%), calcium decreased (8%), diarrhea (8%), differentiation syndrome (7%), non-infectious leukocytosis (6%), tumor lysis syndrome (6%), and nausea (5%)
   
Serious adverse reactions were reported in 77.1% of patients. The most frequent serious adverse reactions (≥2%) were leukocytosis (10%), diarrhea (6%), nausea (5%), vomiting (3%), decreased appetite (3%), tumor lysis syndrome (5%), and differentiation syndrome (8%). Differentiation syndrome events characterized as serious included pyrexia, renal failure acute, hypoxia, respiratory failure, and multi-organ failure
 
LACTATION
 
Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with IDHIFA and for at least 1 month after the last dose.
 
Please see full Prescribing Information, including Boxed WARNING.
 
 
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Celgene Corporation, 8‌6‌ Mo‌rris Av‌enu‌e, ‌Su‌mm‌it,‌ ‌N‌ew Je‌r‌sey 07‌9‌0‌1
 
 
 
 
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