Inotuzumab Ozogamicin

BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B-cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

1); after a second or greater relapse; and in those with refractory disease. Patients with Philadelphia chromosome positive (Ph+) disease should have exhausted relevant BCR-ABL targeting treatment options.

BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive (Ph+) relapsed or refractory B cell precursor ALL should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

BESPONSA (inotuzumab ozogamicin for injection) is indicated for: • Monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada the safety and efficacy of BESPONSA in the pediatric population has not been established; therefore, Health Canada has not authorized an indication for pediatric use.

3 Pharmacokinetics, Special Populations and Conditions). 2 Geriatrics Geriatrics (> 65 years of age): In a randomized clinical study of BESPONSA for the treatment of patients with ALL (Study 1), 30/164 (18%) patients treated with BESPONSA were ≥65 years of age.

No overall differences were observed in the safety and efficacy of BESPONSA between patients who were ˂65 and ≥65 years of age. However, increased age was associated with an increased risk of venoocclusive disease/sinusoidal obstruction syndrome (VOD/SOS) after hematopoietic stem cell transplant (HSCT) (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic, Hepatotoxicity, including VOD/SOS).