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HomeAboutDosingEfficacyAdult: Relapsed or
Refractory Patients
With Ph- or Ph+ ALLPediatric: Relapsed or
Refractory CD22-
Positive Patients With
B-cell Precursor ALLSafetySafetyAdult SafetyPediatric SafetySavings & SupportSavings & SupportEventsMaterialsVideosPersonalized patient supportOrdering BESPONSANCCN Guidelines® Recommendations
Prescribing InformationIndicationPatient Site
Reach for remission with BESPONSA®
(inotuzumab ozogamicin)For adult and pediatric patients aged 1 year and older with CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL)1

Example

PP-INO-USA-0641

The analysis of OS did not meet a prespecified boundary for statistical significance of P=0.0104.3
SEE ADDITIONAL ADULT EFFICACY DATA ›

Study design: INO-VATE ALL was a Phase 3, open-label, randomized (1:1) study of BESPONSA vs investigator’s choice of SC in 326 adult patients with relapsed or refractory B-cell precursor ALL. SC included FLAG, HiDAC, or Ara-C + MXN. All patients were required to have ≥5% bone marrow blasts and to have received 1 or 2 previous induction chemotherapy regimens for B-cell precursor ALL. Patients with Ph+ B-cell precursor ALL were required to have failed treatment with ≥1 TKI and SC. Single-agent BESPONSA was given by 1-hour IV infusion in 3 fractionated doses at 1.8 mg/m2 each 3- to 4-week cycle, reduced to 3 fractionated doses at 1.5 mg/m2 per cycle after achieving CR/CRi, for up to 6 cycles. For patients proceeding to HSCT, the recommended treatment duration with BESPONSA is 2 cycles. Patients who do not achieve a CR or CRi within 3 cycles should discontinue treatment.1,4
SEE ADULT CLINICAL TRIAL DETAILS ›


The efficacy of BESPONSA was established on the basis of CR, duration of CR, and proportion of MRD-negative CR (<1 x 10-4 of bone marrow nucleated cells by flow cytometry) in the first 218 adult patients randomized.1

 Clinical Study Results

The efficacy and safety of BESPONSA were evaluated in clinical trials of adult and pediatric patients.1

 Review efficacy dataLoading BESPONSA Safety Profile

Review the safety profile of BESPONSA, including the BOXED WARNING.

 Review safety dataLoading Dosing & Administration

BESPONSA offers convenient 1‑hour dosing by IV infusion for adult and pediatric patients and can be administered in the outpatient setting.1

 Learn more about dosingLoading

Inotuzumab ozogamicin (BESPONSA®) is a recommended treatment option in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)5

  • For adults with Ph– relapsed or refractory B-cell precursor ALL: Category 1
  • For adults with Ph+ relapsed or refractory B-cell precursor ALL: Category 2A
 Review recommendations Loading BESPONSA is FDA approved to treat pediatric patients aged 1 year and older with CD22-positive B-cell precursor ALL1 See pediatric efficacy and safety dataLoadingReferencesCR, per Endpoint Adjudication Committee (EAC), was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100 x 109/L and ANC ≥1 x 109/L), and resolution of any extramedullary disease (EMD). CRi, per EAC, was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100 × 109/L and/or ANC <1 × 109/L), and resolution of any EMD.1CR, per Endpoint Adjudication Committee (EAC), was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100 x 109/L and ANC ≥1 x 109/L), and resolution of any extramedullary disease (EMD). CRi, per EAC, was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100 × 109/L and/or ANC <1 × 109/L), and resolution of any EMD.11-sided P value using chi-squared test.1MRD-negativity was defined as the number of patients who achieved MRD negativity: flow cytometry as leukemic cells comprising <1 x 10-4 (<0.01%) of bone marrow nucleated cells.11-sided P value using log-rank test.2,4ReferencesCR, per Endpoint Adjudication Committee (EAC), was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100 x 109/L and ANC ≥1 x 109/L), and resolution of any extramedullary disease (EMD). CRi, per EAC, was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100 × 109/L and/or ANC <1 × 109/L), and resolution of any EMD.1CR, per Endpoint Adjudication Committee (EAC), was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets ≥100 x 109/L and ANC ≥1 x 109/L), and resolution of any extramedullary disease (EMD). CRi, per EAC, was defined as <5% blasts in the bone marrow and the absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets <100 × 109/L and/or ANC <1 × 109/L), and resolution of any EMD.11-sided P value using chi-squared test.1MRD-negativity was defined as the number of patients who achieved MRD negativity: flow cytometry as leukemic cells comprising <1 x 10-4 (<0.01%) of bone marrow nucleated cells.11-sided P value using log-rank test.2,4ANC=absolute neutrophil count; Ara-C + MXN=cytarabine + mitoxantrone; CI=confidence interval; CR=complete remission; CRi=complete remission with incomplete hematologic recovery; FLAG=fludarabine + cytarabine + granulocyte colony-stimulating factor; HiDAC=high-dose cytarabine; HSCT=hematopoietic stem cell transplant; IV=intravenous; MRD=minimal residual disease; OS=overall survival; Ph–=Philadelphia chromosome–negative; Ph+=Philadelphia chromosome–positive; TKI=tyrosine kinase inhibitor.
ReferencesBESPONSA Prescribing Information. New York, NY: Pfizer Inc. Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019;125(14):2474-2487. Data on file. Pfizer Inc., New York, NY. Kantarjian HM, DeAngelo DJ, Stelljes M, et al. Inotuzumab ozogamicin versus standard therapy for acute lymphoblastic leukemia. N Engl J Med. 2016;375(8):740-753.  Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia V.2.2020. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed November 15, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.

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PP-MCL-USA-0367
INDICATIONBESPONSA® (inotuzumab ozogamicin) is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Important Safety Information

WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST–HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY (NRM):

  • Hepatotoxicity, including fatal and life-threatening VOD, occurred in patients who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment. The use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD
  • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles
  • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice
  • There was a higher post-HSCT NRM rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate

Hepatotoxicity, Including Hepatic VOD: In adult patients in the INO-VATE ALL trial, hepatotoxicity, including fatal and life-threatening VOD, occurred in 23/164 patients (14%) during or following treatment with BESPONSA or following subsequent HSCT. VOD was reported up to 56 days after the last dose during treatment or follow-up without an intervening HSCT. The median time from HSCT to onset of VOD was 15 days.

VOD occurred in 8/53 (15%) of pediatric patients treated with single agent BESPONSA. Among the 26 pediatric patients who underwent HSCT, VOD occurred in 5 (19%) patients.

Patients with prior VOD or serious ongoing liver disease are at an increased risk of worsening liver disease, including development of VOD, following treatment with BESPONSA. Monitor closely for signs and symptoms of VOD; these may include elevations in total bilirubin, hepatomegaly (which may be painful), rapid weight gain, and ascites. For patients proceeding to HSCT, the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for patients who do not achieve a CR or CRi and MRD-negativity after 2 cycles. Monitor liver tests closely during the first month post HSCT, then less frequently thereafter, according to standard medical practice.

Grade 3/4 increases in aspartate aminotransferase, alanine aminotransferase, and total bilirubin occurred in 7/160 (4%), 7/161 (4%), and 8/161 (5%) adult patients, respectively. In a study of pediatric patients, liver test abnormalities occurred, with Grade 3/4 increases in AST, ALT, and blood bilirubin in 11/53 (21%), 11/53 (21%), and 5/53 (9%) of pediatric patients, respectively.

Increased Risk of Post-HSCT Non-Relapse Mortality (NRM): In adult patients in the INO-VATE ALL trial, there was a higher post-HSCT NRM rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate. The rate of post-HSCT NRM was 31/79 (39%) with BESPONSA and 8/35 (23%) with investigator’s choice of chemotherapy. In the BESPONSA arm, the most common causes of post-HSCT NRM included VOD and infections. In a study of pediatric patients, 26/53 patients (49%) had a follow-up HSCT. The post-HSCT NRM rate was 7/26 (27%). Monitor closely for toxicities post HSCT, including signs and symptoms of infection and VOD.

Myelosuppression: Myelosuppression, and severe, life-threatening, and fatal complications of myelosuppression, including hemorrhagic events and infections, have occurred with BESPONSA. In adult patients in the INO-VATE ALL trial, thrombocytopenia and neutropenia were reported in 83/164 patients (51%) and 81/164 patients (49%), respectively. Febrile neutropenia was reported in 43/164 adult patients (26%).

In a study of pediatric patients, Grade 3 or 4 thrombocytopenia occurred in 24/53 (45%) patients and grade 3 or 4 neutropenia in 21/53 (40%) patients. Infections occurred in 23/53 (43%) patients, and hemorrhage occurred in 22/53 (42%) patients. The most common types of hemorrhage were hematoma in 8/53 (15%), mouth hemorrhage in 6/53 (11%), and epistaxis in 6/53 (11%) patients.

Monitor complete blood counts prior to each dose of BESPONSA and monitor for signs and symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment, and provide appropriate management. As appropriate, administer prophylactic anti-infectives during and after treatment with BESPONSA. Dose interruption, dose reduction, or permanent discontinuation may be required.

Infusion-Related Reactions: Infusion-related reactions (all Grade 2) were reported in 4/164 adult patients (2%). In pediatric patients, infusion-related reactions occurred in 4/53 (8%) patients. Premedicate with a corticosteroid, an antipyretic, and an antihistamine prior to dosing. Monitor patients closely during and for at least 1 hour after the end of the infusion for the potential onset of infusion-related reactions, including symptoms such as fever, chills, rash, or breathing problems. Interrupt the infusion and institute appropriate medical management if an infusion-related reaction occurs. Depending on the severity, consider discontinuation of the infusion or administration of steroids and antihistamines. For severe or life-threatening infusion reactions, permanently discontinue BESPONSA.

QT Interval Prolongation: Increases in QT interval corrected for heart rate using Fridericia’s formula (QTcF) of ≥60 msec from baseline occurred in 4/162 adult patients (3%). In a study of pediatric patients, increases in QTcF of >60 msec from baseline occurred in 7/49 (14%) patients, and 3/52 (6%) of patients had QTcF values >500 msec. Administer BESPONSA with caution in patients who have a history of or predisposition to QTc prolongation, who are taking medicinal products that are known to prolong QT interval, and in patients who have electrolyte disturbances. Obtain electrocardiograms and electrolytes prior to treatment and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

Embryo-Fetal Toxicity: BESPONSA can cause embryo-fetal harm. Apprise pregnant women of the potential risk to the fetus. Advise males and females of reproductive potential to use effective contraception during BESPONSA treatment and for at least 5 and 8 months after the last dose, respectively. Advise women to contact their healthcare provider if they become pregnant or if pregnancy is suspected during treatment with BESPONSA.

Adverse Reactions: The most common (≥20%) adverse reactions in adult and pediatric patients, including laboratory abnormalities, are thrombocytopenia, pyrexia, neutropenia, infection, anemia, vomiting, leukopenia, hemorrhage, fatigue, nausea, febrile neutropenia, headache, transaminases increased, abdominal pain, gamma-glutamyltransferase increased, and hyperbilirubinemia.

Nursing Mothers: Advise women against breastfeeding while receiving BESPONSA and for 2 months after the last dose.


Please see full Prescribing Information, including BOXED WARNING.

INDICATION BESPONSA® (inotuzumab ozogamicin) is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year of age and older.