This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog OutTherapy AreasProductsOrder VaccinesOrder SamplesOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

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
Pediatric Clinical Data

CR

DoCR

MRD

Tab Number 4

Tab Number 5

BESPONSA efficacy in pediatric patients was established in the ITCC-059 trial on the basis of the complete remission (CR) rate1
  • The primary objective was to establish the preliminary activity of BESPONSA
  • Secondary objectives included safety, other measures of antileukemic activity, pharmacodynamics analysis, and pharmacokinetic parameters
  • In all, 22/53 (42%), (95% CI: 28.1%-55.9%) of pediatric patients taking BESPONSA achieved CR2*
CR 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 × 109/L and ANC ≥1 × 109/L) and resolution of any extramedullary disease, duration of CR, and proportion of patients with MRD negative CR (MRD was defined by leukemic cells comprising <1 × 109/L [<0.01%] of bone marrow nucleated cells by flow cytometry or by PCR).
ANC=absolute neutrophil count; CI=confidence interval; MRD=minimal residual disease; PCR=polymerase chain reaction.
ReferencesPennesi E, Michels N, Brivio E, et al. Inotuzumab ozogamicin as single agent in pediatric patients with relapsed and refractory acute lymphoblastic leukemia: results from a phase II trial. Leukemia. 2022;36(6):1516-1524.BESPONSA Prescribing Information. New York, NY: Pfizer Inc.
BESPONSA efficacy in pediatric patients was also established in the ITCC-059 trial on the basis of the duration of CR (DoCR)1

CR=complete remission; NE=not evaluable.

ReferenceBESPONSA Prescribing Information. New York, NY: Pfizer Inc.
BESPONSA pediatric patients in the ITCC-059 trial achieved minimal residual disease (MRD) negativity in more than 95% of patients with CR1
  • The MRD negativity rate in patients with CR was 21/22 (95.5%), (95% CI: 77.2-99.9), based on flow cytometry, and 19/22 (86.4%), (95% CI: 65.1-97.1), based on RQ-PCR1
CI=confidence interval; CR=complete remission; RQ-PCR=real-time quantitative polymerase chain reaction.
ReferenceBESPONSA Prescribing Information. New York, NY: Pfizer Inc.

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2025 Pfizer Inc. All rights reserved.

PP-INO-USA-0658
You are now leaving PfizerYou are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.

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.