The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Combination Therapy in Newly-Diagnosed De Novo CD33-positive AML
The safety of MYLOTARG in first-line combination therapy was evaluated in two prospective clinical trials, Study ALFA-0701 in adults and Study AAML0531 in pediatric patients.
Study ALFA-0701
The safety evaluation of MYLOTARG (3 mg/m2 Day 1, 4 and 7 in combination with daunorubicin and cytarabine [DA]) in adults is based on data from ALFA-0701 for 131 patients treated with MYLOTARG plus DA and in 137 patients treated with DA alone [see Clinical Studies (14.1)]. In this study, 123 patients received all 3 fractionated doses of MYLOTARG and 7 patients missed at least 1 dose, with a mean total dose administered during induction of 14.51 mg (range: 4.6–18.0). MYLOTARG was received by 91 (70%) patients in the MYLOTARG arm during Consolidation 1 and 64 (49%) patients in the MYLOTARG arm during Consolidation 2.
Safety data consisting of selected TEAEs considered most important for understanding the safety profile of MYLOTARG as well as all adverse events (AEs) that led to the permanent discontinuation of treatment were retrospectively collected. The selected TEAEs consisted of all grades hemorrhages, all grades VOD, and severe infections.
Discontinuation due to any adverse reaction occurred in 31% of patients in the MYLOTARG arm versus 7% in the DA arm. The most frequent (greater than or equal to 1%) adverse reactions for patients treated with MYLOTARG that led to permanent discontinuation were thrombocytopenia (15%), VOD (3%), and septic shock (2%).
Fatal adverse reactions occurred in 8 patients (6%) in the MYLOTARG arm versus 3 patients (2%) in the DA arm. In the MYLOTARG arm, 3 patients died of VOD, 4 patients died of hemorrhage-related events (CNS hemorrhage, hemorrhagic shock), and 1 patient died of suspected cardiac cause. In the DA arm, 3 patients died of sepsis.
| MYLOTARG + Daunorubicin + Cytarabine (n, %) | Daunorubicin + Cytarabine (n, %) | |
|---|---|---|
| Abbreviations: AML=acute myeloid leukemia; N=number of patients; PT=preferred term. | ||
| Induction | N = 131 | N = 137 |
| Infection* | 61 (47%) | 53 (39%) |
| Hemorrhage† | 24 (18%) | 12 (9%) |
| Veno-occlusive liver disease‡ | 3 (2%) | 0 |
| Consolidation 1 | N = 91 | N = 103 |
| Infection* | 50 (55%) | 43 (42%) |
| Hemorrhage† | 5 (5%) | 0 |
| Veno-occlusive liver disease‡ | 0 | 0 |
| Consolidation 2 | N = 64 | N = 107 |
| Infection* | 32 (50%) | 54 (50%) |
| Hemorrhage† | 4 (6%) | 0 |
| Veno-occlusive liver disease‡ | 0 | 0 |
All patients in ALFA-0701 developed severe neutropenia, thrombocytopenia and anemia. The incidence of Grade 3–4 thrombocytopenia that was prolonged in the absence of active leukemia was higher in patients treated with MYLOTARG (Table 3).
| MYLOTARG + Daunorubicin + Cytarabine (n/N, %) | Daunorubicin + Cytarabine (n/N, %) | |
|---|---|---|
| ||
| Induction | ||
| Prolonged thrombocytopenia | 19/101 (19%) | 7/97 (7%) |
| Prolonged neutropenia | 3/106 (3%) | 0/101 (0%) |
| Consolidation 1 | ||
| Prolonged thrombocytopenia | 21/87 (24%) | 6/91 (7%) |
| Prolonged neutropenia | 3/88 (3%) | 1/97 (1%) |
| Consolidation 2 | ||
| Prolonged thrombocytopenia | 22/62 (35%) | 25/103 (24%) |
| Prolonged neutropenia | 1/62 (2%) | 2/105 (2%) |
Table 4 summarizes shifts in selected chemistry abnormalities by treatment arm for patients treated in ALFA-0701.
| MYLOTARG + Daunorubicin + Cytarabine | Daunorubicin + Cytarabine | |||
|---|---|---|---|---|
| Laboratory Abnormality | Subjects (n) with baseline Grade less than or equal to 2 | Progressed to Grade greater than or equal to 3 (n, %) | Subjects (n) with baseline Grade less than or equal to 2 | Progressed to Grade greater than or equal to 3 (n, %) |
| Hypophosphatemia | 117 | 75 (64%) | 127 | 52 (41%) |
| Hypokalemia | 127 | 73 (57%) | 133 | 41 (31%) |
| Hyponatremia | 129 | 57 (44%) | 134 | 36 (27%) |
| Alkaline phosphatase increased | 120 | 16 (13%) | 128 | 7 (5%) |
| Aspartate aminotransferase increased | 126 | 18 (14%) | 132 | 11 (8%) |
| Alanine aminotransferase increased | 124 | 13 (10%) | 132 | 20 (15%) |
| Blood bilirubin increased | 119 | 9 (8%) | 126 | 5 (4%) |
Study AAML0531
The safety evaluation of MYLOTARG in combination with chemotherapy in pediatric patients is based on data from AAML0531 [see Clinical Studies (14.1)] in randomized and treated patients (N = 520 MYLOTARG and chemotherapy and N = 517 chemotherapy alone). In the MYLOTARG arm of this study, 520 patients received Induction 1 and 326 patients received Intensification 2.
Safety data collected included only Grade 3 and 4 nonhematologic adverse events, deaths, VOD/SOS, and prolongation of neutropenia and thrombocytopenia.
Table 5 shows the Grade 3 or 4 adverse reactions (≥5%) in the MYLOTARG + chemotherapy or chemotherapy alone arms in patients with newly-diagnosed de novo AML in AAML0531.
In the MYLOTARG + chemotherapy arm, fatal adverse reactions (by grouped terms) were infection (14 [3%]), multi-organ failure (5 [1%]), anemia (1 [<1%]), and hemorrhage (3 [<1%]). In the chemotherapy arm, fatal adverse reactions included infection (7 [1%]), multi-organ failure (6 [1%]), hepatic failure (1 [<1%]), hypotension (3 [<1%]), and hemorrhage (3 [<1%]).
| Induction 1 | Intensification 2 | |||
|---|---|---|---|---|
| MYLOTARG + Chemotherapy N = 520 n (%) | Chemotherapy alone N = 517 n (%) | MYLOTARG + Chemotherapy N = 326 n (%) | Chemotherapy alone N = 304 n (%) | |
| ||||
| Infection* | 186 (36%) | 181 (35%) | 220 (67%) | 211 (69%) |
| Febrile neutropenia | 167 (32%) | 157 (30%) | 79 (24%) | 68 (22%) |
| Decreased appetite | 78 (15%) | 79 (15%) | 61 (19%) | 36 (12%) |
| Hyperglycemia | 59 (11%) | 55 (11%) | 36 (11%) | 28 (9%) |
| Mucositis* | 55 (11%) | 64 (12%) | 25 (8%) | 15 (5%) |
| Hypoxia | 35 (7%) | 26 (5%) | 19 (6%) | 22 (7%) |
| Hemorrhage* | 36 (7%) | 19 (4%) | 19 (6%) | 9 (3%) |
| Transaminase Increased* | 33 (6%) | 24 (5%) | 23 (7%) | 13 (4%) |
| Diarrhea | 21 (4%) | 36 (7%) | 15 (5%) | 10 (3%) |
| Nausea | 21 (4%) | 18 (4%) | 23 (7%) | 10 (3%) |
| Hypotension | 16 (3%) | 26 (5%) | 28 (9%) | 23 (8%) |
The addition of MYLOTARG to chemotherapy was associated with a higher incidence of prolonged thrombocytopenia and neutropenia particularly when used in Intensification 2. During Intensification 2, prolonged thrombocytopenia (platelets <50 Gi/L lasting past cycle Day 42 in the absence of active leukemia) was reported in 64% (190/297) of patients in the MYLOTARG + chemotherapy arm compared with 55% (146/264) in the chemotherapy alone arm. Prolonged neutropenia (neutrophils <0.5 Gi/L lasting past cycle Day 42 in the absence of active leukemia) occurred in 47% (142/300) versus 43% (118/275) of patients, respectively. The prolonged cytopenias were associated with more deaths in remission in the MYLOTARG + chemotherapy arm (29 [5%]) compared to the chemotherapy alone arm (15 [3%]).
VOD events were reported in 25 (5%) patients in the MYLOTARG + chemotherapy arm as well as 25 (5%) of the chemotherapy alone arm. VOD was fatal in 2 (<1%) and 7 (1%) patients in the MYLOTARG + chemotherapy arm and chemotherapy alone arm, respectively.
Monotherapy for Newly-Diagnosed CD33-positive AML
The safety evaluation of MYLOTARG (6 mg/m2 then 3 mg/m2, with 7 days between the doses) as monotherapy is based on a randomized, open-label, Phase 3 trial of MYLOTARG (N=118) versus best supportive care (BSC) (N=119) in patients with previously untreated AML who were considered ineligible for intensive chemotherapy in Study AML-19 [see Clinical Studies (14.1)].
The overall incidence of any Grade adverse reactions reported in AML-19 was 87% in the MYLOTARG arm and 90% in the BSC arm. The incidence of Grade greater than or equal to 3 adverse reactions was 61% in the MYLOTARG arm and 68% in the BSC arm. Death due to any Adverse Event was reported in the MYLOTARG arm of 19 (17%) compared to the BSC arm of 23 (20%).
| MYLOTARG n=111 | Best Supportive Care n=114 | |||
|---|---|---|---|---|
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Liver | 57 (51%) | 8 (7%) | 52 (46%) | 7 (6%) |
| Fatigue | 51 (46%) | 13 (12%) | 69 (61%) | 24 (21%) |
| Infection | 49 (44%) | 39 (35%) | 48 (42%) | 39 (34%) |
| Cardiac | 31 (28%) | 7 (6%) | 37 (33%) | 16 (14%) |
| Bleeding | 28 (25%) | 14 (13%) | 34 (30%) | 14 (12%) |
| Febrile neutropenia | 20 (18%) | 20 (18%) | 27 (24%) | 27 (24%) |
| Metabolic | 18 (16%) | 4 (4%) | 17 (15%) | 7 (6%) |
| Renal | 7 (6%) | 4 (4%) | 9 (8%) | 5 (4%) |
Monotherapy for Relapsed or Refractory CD33-positive AML
The adverse reactions described in this section reflect exposure to MYLOTARG 3 mg/m2 on Days 1, 4 and 7 as monotherapy in 57 patients with relapsed AML treated on MyloFrance-1 [see Clinical Studies (14.1)]. All 57 (100%) patients received the 3 planned doses of MYLOTARG.
During the treatment period, Grade 3 treatment-emergent adverse events (TEAEs) that occurred in greater than 1% patients included sepsis (32%), fever (16%), rash (11%), pneumonia (7%), bleeding (7%), mucositis (4%), pain (4%), diarrhea (2%), headaches (2%), tachycardia (2%), and lung edema (2%). No Grade 4 toxicity was observed. All grade TEAEs that occurred in greater than 15% of patients included fever (79%), infection (42%), increased AST (40%), bleeding (23%), nausea and vomiting (21%), constipation (21%), mucositis (21%), headache (19%), increased ALT (16%), and rash (16%). No infectious deaths occurred. Grade 1 or 2 hyperbilirubinemia developed in 4 (7%) patients. No episodes of VOD occurred. Seven patients received HSCT after MYLOTARG treatment. Three patients received an allogeneic BMT and 4 patients were treated with autologous BMT. No patients developed VOD following HSCT.
The following adverse drug reactions have been identified during post-approval use of MYLOTARG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Neutropenic colitis1
Infections and Infestations: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia1; and bacterial infections including Stenotrophomonas infection
Renal and Urinary Disorders: Hemorrhagic cystitis1
Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonia1
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Combination Therapy in Newly-Diagnosed De Novo CD33-positive AML
The safety of MYLOTARG in first-line combination therapy was evaluated in two prospective clinical trials, Study ALFA-0701 in adults and Study AAML0531 in pediatric patients.
Study ALFA-0701
The safety evaluation of MYLOTARG (3 mg/m2 Day 1, 4 and 7 in combination with daunorubicin and cytarabine [DA]) in adults is based on data from ALFA-0701 for 131 patients treated with MYLOTARG plus DA and in 137 patients treated with DA alone [see Clinical Studies (14.1)]. In this study, 123 patients received all 3 fractionated doses of MYLOTARG and 7 patients missed at least 1 dose, with a mean total dose administered during induction of 14.51 mg (range: 4.6–18.0). MYLOTARG was received by 91 (70%) patients in the MYLOTARG arm during Consolidation 1 and 64 (49%) patients in the MYLOTARG arm during Consolidation 2.
Safety data consisting of selected TEAEs considered most important for understanding the safety profile of MYLOTARG as well as all adverse events (AEs) that led to the permanent discontinuation of treatment were retrospectively collected. The selected TEAEs consisted of all grades hemorrhages, all grades VOD, and severe infections.
Discontinuation due to any adverse reaction occurred in 31% of patients in the MYLOTARG arm versus 7% in the DA arm. The most frequent (greater than or equal to 1%) adverse reactions for patients treated with MYLOTARG that led to permanent discontinuation were thrombocytopenia (15%), VOD (3%), and septic shock (2%).
Fatal adverse reactions occurred in 8 patients (6%) in the MYLOTARG arm versus 3 patients (2%) in the DA arm. In the MYLOTARG arm, 3 patients died of VOD, 4 patients died of hemorrhage-related events (CNS hemorrhage, hemorrhagic shock), and 1 patient died of suspected cardiac cause. In the DA arm, 3 patients died of sepsis.
| MYLOTARG + Daunorubicin + Cytarabine (n, %) | Daunorubicin + Cytarabine (n, %) | |
|---|---|---|
| Abbreviations: AML=acute myeloid leukemia; N=number of patients; PT=preferred term. | ||
| Induction | N = 131 | N = 137 |
| Infection* | 61 (47%) | 53 (39%) |
| Hemorrhage† | 24 (18%) | 12 (9%) |
| Veno-occlusive liver disease‡ | 3 (2%) | 0 |
| Consolidation 1 | N = 91 | N = 103 |
| Infection* | 50 (55%) | 43 (42%) |
| Hemorrhage† | 5 (5%) | 0 |
| Veno-occlusive liver disease‡ | 0 | 0 |
| Consolidation 2 | N = 64 | N = 107 |
| Infection* | 32 (50%) | 54 (50%) |
| Hemorrhage† | 4 (6%) | 0 |
| Veno-occlusive liver disease‡ | 0 | 0 |
All patients in ALFA-0701 developed severe neutropenia, thrombocytopenia and anemia. The incidence of Grade 3–4 thrombocytopenia that was prolonged in the absence of active leukemia was higher in patients treated with MYLOTARG (Table 3).
| MYLOTARG + Daunorubicin + Cytarabine (n/N, %) | Daunorubicin + Cytarabine (n/N, %) | |
|---|---|---|
| ||
| Induction | ||
| Prolonged thrombocytopenia | 19/101 (19%) | 7/97 (7%) |
| Prolonged neutropenia | 3/106 (3%) | 0/101 (0%) |
| Consolidation 1 | ||
| Prolonged thrombocytopenia | 21/87 (24%) | 6/91 (7%) |
| Prolonged neutropenia | 3/88 (3%) | 1/97 (1%) |
| Consolidation 2 | ||
| Prolonged thrombocytopenia | 22/62 (35%) | 25/103 (24%) |
| Prolonged neutropenia | 1/62 (2%) | 2/105 (2%) |
Table 4 summarizes shifts in selected chemistry abnormalities by treatment arm for patients treated in ALFA-0701.
| MYLOTARG + Daunorubicin + Cytarabine | Daunorubicin + Cytarabine | |||
|---|---|---|---|---|
| Laboratory Abnormality | Subjects (n) with baseline Grade less than or equal to 2 | Progressed to Grade greater than or equal to 3 (n, %) | Subjects (n) with baseline Grade less than or equal to 2 | Progressed to Grade greater than or equal to 3 (n, %) |
| Hypophosphatemia | 117 | 75 (64%) | 127 | 52 (41%) |
| Hypokalemia | 127 | 73 (57%) | 133 | 41 (31%) |
| Hyponatremia | 129 | 57 (44%) | 134 | 36 (27%) |
| Alkaline phosphatase increased | 120 | 16 (13%) | 128 | 7 (5%) |
| Aspartate aminotransferase increased | 126 | 18 (14%) | 132 | 11 (8%) |
| Alanine aminotransferase increased | 124 | 13 (10%) | 132 | 20 (15%) |
| Blood bilirubin increased | 119 | 9 (8%) | 126 | 5 (4%) |
Study AAML0531
The safety evaluation of MYLOTARG in combination with chemotherapy in pediatric patients is based on data from AAML0531 [see Clinical Studies (14.1)] in randomized and treated patients (N = 520 MYLOTARG and chemotherapy and N = 517 chemotherapy alone). In the MYLOTARG arm of this study, 520 patients received Induction 1 and 326 patients received Intensification 2.
Safety data collected included only Grade 3 and 4 nonhematologic adverse events, deaths, VOD/SOS, and prolongation of neutropenia and thrombocytopenia.
Table 5 shows the Grade 3 or 4 adverse reactions (≥5%) in the MYLOTARG + chemotherapy or chemotherapy alone arms in patients with newly-diagnosed de novo AML in AAML0531.
In the MYLOTARG + chemotherapy arm, fatal adverse reactions (by grouped terms) were infection (14 [3%]), multi-organ failure (5 [1%]), anemia (1 [<1%]), and hemorrhage (3 [<1%]). In the chemotherapy arm, fatal adverse reactions included infection (7 [1%]), multi-organ failure (6 [1%]), hepatic failure (1 [<1%]), hypotension (3 [<1%]), and hemorrhage (3 [<1%]).
| Induction 1 | Intensification 2 | |||
|---|---|---|---|---|
| MYLOTARG + Chemotherapy N = 520 n (%) | Chemotherapy alone N = 517 n (%) | MYLOTARG + Chemotherapy N = 326 n (%) | Chemotherapy alone N = 304 n (%) | |
| ||||
| Infection* | 186 (36%) | 181 (35%) | 220 (67%) | 211 (69%) |
| Febrile neutropenia | 167 (32%) | 157 (30%) | 79 (24%) | 68 (22%) |
| Decreased appetite | 78 (15%) | 79 (15%) | 61 (19%) | 36 (12%) |
| Hyperglycemia | 59 (11%) | 55 (11%) | 36 (11%) | 28 (9%) |
| Mucositis* | 55 (11%) | 64 (12%) | 25 (8%) | 15 (5%) |
| Hypoxia | 35 (7%) | 26 (5%) | 19 (6%) | 22 (7%) |
| Hemorrhage* | 36 (7%) | 19 (4%) | 19 (6%) | 9 (3%) |
| Transaminase Increased* | 33 (6%) | 24 (5%) | 23 (7%) | 13 (4%) |
| Diarrhea | 21 (4%) | 36 (7%) | 15 (5%) | 10 (3%) |
| Nausea | 21 (4%) | 18 (4%) | 23 (7%) | 10 (3%) |
| Hypotension | 16 (3%) | 26 (5%) | 28 (9%) | 23 (8%) |
The addition of MYLOTARG to chemotherapy was associated with a higher incidence of prolonged thrombocytopenia and neutropenia particularly when used in Intensification 2. During Intensification 2, prolonged thrombocytopenia (platelets <50 Gi/L lasting past cycle Day 42 in the absence of active leukemia) was reported in 64% (190/297) of patients in the MYLOTARG + chemotherapy arm compared with 55% (146/264) in the chemotherapy alone arm. Prolonged neutropenia (neutrophils <0.5 Gi/L lasting past cycle Day 42 in the absence of active leukemia) occurred in 47% (142/300) versus 43% (118/275) of patients, respectively. The prolonged cytopenias were associated with more deaths in remission in the MYLOTARG + chemotherapy arm (29 [5%]) compared to the chemotherapy alone arm (15 [3%]).
VOD events were reported in 25 (5%) patients in the MYLOTARG + chemotherapy arm as well as 25 (5%) of the chemotherapy alone arm. VOD was fatal in 2 (<1%) and 7 (1%) patients in the MYLOTARG + chemotherapy arm and chemotherapy alone arm, respectively.
Monotherapy for Newly-Diagnosed CD33-positive AML
The safety evaluation of MYLOTARG (6 mg/m2 then 3 mg/m2, with 7 days between the doses) as monotherapy is based on a randomized, open-label, Phase 3 trial of MYLOTARG (N=118) versus best supportive care (BSC) (N=119) in patients with previously untreated AML who were considered ineligible for intensive chemotherapy in Study AML-19 [see Clinical Studies (14.1)].
The overall incidence of any Grade adverse reactions reported in AML-19 was 87% in the MYLOTARG arm and 90% in the BSC arm. The incidence of Grade greater than or equal to 3 adverse reactions was 61% in the MYLOTARG arm and 68% in the BSC arm. Death due to any Adverse Event was reported in the MYLOTARG arm of 19 (17%) compared to the BSC arm of 23 (20%).
| MYLOTARG n=111 | Best Supportive Care n=114 | |||
|---|---|---|---|---|
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Liver | 57 (51%) | 8 (7%) | 52 (46%) | 7 (6%) |
| Fatigue | 51 (46%) | 13 (12%) | 69 (61%) | 24 (21%) |
| Infection | 49 (44%) | 39 (35%) | 48 (42%) | 39 (34%) |
| Cardiac | 31 (28%) | 7 (6%) | 37 (33%) | 16 (14%) |
| Bleeding | 28 (25%) | 14 (13%) | 34 (30%) | 14 (12%) |
| Febrile neutropenia | 20 (18%) | 20 (18%) | 27 (24%) | 27 (24%) |
| Metabolic | 18 (16%) | 4 (4%) | 17 (15%) | 7 (6%) |
| Renal | 7 (6%) | 4 (4%) | 9 (8%) | 5 (4%) |
Monotherapy for Relapsed or Refractory CD33-positive AML
The adverse reactions described in this section reflect exposure to MYLOTARG 3 mg/m2 on Days 1, 4 and 7 as monotherapy in 57 patients with relapsed AML treated on MyloFrance-1 [see Clinical Studies (14.1)]. All 57 (100%) patients received the 3 planned doses of MYLOTARG.
During the treatment period, Grade 3 treatment-emergent adverse events (TEAEs) that occurred in greater than 1% patients included sepsis (32%), fever (16%), rash (11%), pneumonia (7%), bleeding (7%), mucositis (4%), pain (4%), diarrhea (2%), headaches (2%), tachycardia (2%), and lung edema (2%). No Grade 4 toxicity was observed. All grade TEAEs that occurred in greater than 15% of patients included fever (79%), infection (42%), increased AST (40%), bleeding (23%), nausea and vomiting (21%), constipation (21%), mucositis (21%), headache (19%), increased ALT (16%), and rash (16%). No infectious deaths occurred. Grade 1 or 2 hyperbilirubinemia developed in 4 (7%) patients. No episodes of VOD occurred. Seven patients received HSCT after MYLOTARG treatment. Three patients received an allogeneic BMT and 4 patients were treated with autologous BMT. No patients developed VOD following HSCT.
The following adverse drug reactions have been identified during post-approval use of MYLOTARG. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Neutropenic colitis1
Infections and Infestations: fungal lung infections including Pulmonary mycosis and Pneumocystis jirovecii pneumonia1; and bacterial infections including Stenotrophomonas infection
Renal and Urinary Disorders: Hemorrhagic cystitis1
Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonia1
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