Selected Adverse Events

Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)1

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection

The rate of infection was similar with MYLOTARG™ + chemotherapy vs chemotherapy alone

  • MYLOTARG™ + chemotherapy arm:

    • All-causality severe (Grade ≥ 3) infections were reported in 102 (77.9%) patients
    • Treatment-related death due to septic shock was reported in 1 (0.8%) patients
       
  • MYLOTARG™ + chemotherapy and chemotherapy alone arm:
    • Fatal severe infection was reported in 2 (1.5%) patients in the MYLOTARG™ + chemotherapy arm and 4 (2.9%) patients in the chemotherapy alone arm

*Including fatal outcome

**Only selected safety data were collected in this study of newly diagnosed AML

Reference

  1. MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0093. December 2019

Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)1

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection

VOD was a common (≥ 1%) adverse event with MYLOTARG™ + chemotherapy vs chemotherapy alone

  • MYLOTARG™ + chemotherapy and chemotherapy alone arm:

    • Six (4.6%) patients in the MYLOTARG™ + chemotherapy arm and 2 (1.5%) patients in the chemotherapy alone arm experienced VOD
    • Two (1.5%) patients in the MYLOTARG™ + chemotherapy arm died owing to VOD
    • The two VOD events in the chemotherapy arm occurred after MYLOTARG™ re-treatment for relapse

​​​​​​​*Including fatal outcome.

**Only selected safety data were collected in this study of newly diagnosed AML
VOD, veno-occlusive disease.

Reference

  1. MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0095. December 2019

Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)1

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection

The rate of haemorrhage was higher with MYLOTARG™ + chemotherapy vs chemotherapy alone

  • MYLOTARG™ + chemotherapy arm:

    • The most frequent Grade 3 bleeding/haemorrhagic reactions were haemoptysis (3.1%), haematuria (2.3%) and epistaxis (1.5%)
    • Grade 4 bleeding/haemorrhagic reactions were reported in 4 (3.1%) patients (gastrointestinal haemorrhage, haemorrhage and pulmonary alveolar haemorrhage [2 patients])
    • Fatal bleeding/haemorrhagic reactions were reported in 3 (2.3%) patients (cerebral haematoma, intracranial haematoma and subdural haematoma)

*Including fatal outcome.

**Only selected safety data were collected in this study of newly diagnosed AML

Reference

  1. MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0092. December 2019

Selected** adverse reactions in patients who received MYLOTARG in combination therapy study (ALFA-0701)1

The most frequent (≥ 1%) adverse reactions that led to permanent discontinuation in the combination therapy study were thrombocytopenia, VOD, haemorrhage and infection

Severe persistent thrombocytopenia* was observed in 22 (20.4%) patients in the MYLOTARG™ + chemotherapy arm

  • MYLOTARG™ + chemotherapy arm:

    • The median time to recovery of platelets following induction was 34 days 

*Thrombocytopenia with platelet counts < 50,000/mm3 persisting 45 days after the start of therapy for responding patients (CR and CRp). 

**Only selected safety data were collected in this study of newly diagnosed AML

CR, complete remission; CRp, complete remission with incomplete platelet recovery.

Reference

  1. MYLOTARG™ Summary of Marketing Product Characteristics.

PP-MYL-GBR-0094. December 2019