BESPONSA

Besponsa is a medication specifically designed to combat B-cell precursor acute lymphoblastic leukemia (ALL), a form of blood cancer that affects B cells. It is primarily used as a standalone treatment for adults who have experienced a relapse or have not shown positive responses to prior therapies.

BESPONSA should be given in cycles lasting 3 to 4 weeks. If a patient is going to have a haematopoietic stem cell transplant (HSCT), the recommended treatment duration is 2 cycles.

Inotuzumab ozogamicin, marketed as Besponsa, is a medication that combines an antibody with a drug and is used to treat B-cell precursor acute lymphoblastic leukemia (ALL) that has relapsed or is refractory.

Besponsa is a medication used to treat acute lymphoblastic leukaemia (ALL) in adults. Its active ingredient, inotuzumab ozogamicin, is classified as an antineoplastic agent, which specifically targets cancer cells.

For patients who achieve a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), it is recommended to administer a total dose of 1.5 mg/m2 of BESPONSA per treatment cycle. This should be divided into three doses, with 0.5 mg/m2 given on Day 1, Day 8, and Day 15. Each treatment cycle lasts for 4 weeks.

The use of inotuzumab resulted in a significantly longer median progression-free survival of 5.0 months compared to 1.8 months with standard of care (p < .001). Additionally, the median survival was 7.7 months with inotuzumab compared to 6.7 months with standard of care (HR 0.77; p = .02). The 2-year survival rate was also higher with inotuzumab at 23% compared to 10% with standard of care.

The median overall survival for inotuzumab ozogamicin was 7.7 months (95% CI, 6.0-9.2), compared to 6.7 months (95% CI, 4.9-8.3) for standard care. The 2-year overall survival rate was 23% (95% CI, 16%-30%) for inotuzumab ozogamicin, compared to 10% (95% CI, 5%-16%) for standard care (Fig. 2C).

In a study involving 53 pediatric patients with BCP-ALL who were treated with InO, the same covariates were identified. It is important to note that ADCs, including InO, cannot pass through the blood-brain barrier, and there is currently no data to support its use for central nervous system ALL.

Clofarabine belongs to a group of drugs known as purine nucleoside antimetabolites. Its mechanism of action involves the eradication of existing cancer cells and the inhibition of the growth of new cancer cells.

If there were no infusion reactions during the previous infusion, start the infusion at a rate of 50 mg/hr. The infusion rate can be increased by 50 mg/hr every 30 minutes, up to a maximum rate of 400 mg/hr. However, if there was an infusion reaction during the previous infusion, administer at a rate of 25 mg/hr.

Inotuzumab ozogamicin (BESPONSA), a drug developed by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc., was approved by the U.S. Food and Drug Administration on Aug. 17, 2017.

In this particular scenario, the use of inotuzumab therapy led to an 80% overall response rate and a median overall survival of 7.7 months. On the other hand, blinatumomab resulted in a 44% overall response rate and a median overall survival of 7.7 months.

For patients who achieve a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), it is recommended to administer a total dose of 1.5 mg/m2 of BESPONSA per treatment cycle. This should be divided into three doses, with 0.5 mg/m2 given on Day 1, Day 8, and Day 15. Each treatment cycle lasts for 4 weeks.

Monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, can be used in immunotherapy to enhance the body’s immune system response against cancer. These antibodies work by inhibiting the growth and spread of tumor cells.

Pembrolizumab (brand name Keytruda) was approved by the FDA on January 26, 2023 for adjuvant treatment in adult patients with stage IB, II, or IIIA non-small cell lung cancer who have undergone resection and platinum-based chemotherapy. The indication is limited to those who have received prior adjuvant chemotherapy.

The drug is eliminated from the body after it is administered. In a 2-compartment model, the elimination half-life at the end of Cycle 4 of administration is approximately 12.3 days.

On November 26, 1997, the US Food and Drug Administration approved rituximab for the treatment of relapsed or refractory, CD20-positive, B-cell, low-grade or follicular non-Hodgkin’s lymphoma (LG/F NHL).

Patients treated with BESPONSA achieved a CR/CRi rate of at least 70%, irrespective of their disease burden.

The drug is eliminated from the body after it is administered. In a 2-compartment model, the elimination half-life at the end of Cycle 4 of administration is approximately 12.3 days.

Out of the 90 patients treated, 52 of them showed responses, resulting in an overall response rate of 58%. The response rates for both weekly and single-dose inotuzumab were similar, as shown in Table 2. The median number of cycles for weekly inotuzumab was 2, ranging from 1 to 6, while for single-dose inotuzumab it was also 2, ranging from 1 to 5.

The 5-year survival rate for this condition is 55%.

Besponsa, an analog of Mylotarg, is an effective treatment for acute lymphoblastic leukemia (ALL) in adults. It works by binding to the CD22 protein found on B-cells in this type of cancer, inhibiting their proliferation.

Pfizer Oncology Together offers financial assistance resources to help patients access their prescribed Oncology medicine, including BESPONSA for injection (inotuzumab ozogamicin).

Inotuzumab ozogamicin, marketed as Besponsa, is a medication that combines an antibody with a drug and is used to treat B-cell precursor acute lymphoblastic leukemia (ALL) that has relapsed or is refractory.

Besponsa (inotuzumab ozogamicin) belongs to the miscellaneous antineoplastics drug class and is frequently prescribed for the treatment of Acute Lymphoblastic Leukemia. The price of Besponsa intravenous powder for injection 0.9 mg is approximately $23,077 for a single powder for injection, which may vary depending on the pharmacy you choose.

Brexucabtagene autoleucel (brand name Tecartus) was approved by the FDA on October 1, 2021 for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adult patients.

Applicant Tradename Estimated Patent Expiration
Wyeth Pharmaceuticals Llc BESPONSA 2035-10-05
Wyeth Pharmaceuticals Llc BESPONSA 2035-02-24
Wyeth Pharmaceuticals Llc BESPONSA 2033-11-20
Wyeth Pharmaceuticals Llc BESPONSA 2026-06-23

BESPONSA (inotuzumab ozogamicin) for Injection comes in the form of a single-dose vial containing a white to off-white lyophilized powder. This powder must be reconstituted and diluted before use.

Pfizer has received approval from the U.S. FDA for BESPONSA® (inotuzumab ozogamicin). This medication is now approved for the treatment of adults who have relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

BESPONSA works by binding to the CD22 cell-surface antigen on B-cells. This causes the ADC-CD22 complex to be internalized, releasing the calicheamicin cytotoxic agent. The cytotoxic agent then destroys the cancer cell.

Initially created at the University of Pennsylvania, the drug utilized a 4-1BB costimulatory domain to improve cellular responses. Novartis, a Swiss-American pharmaceutical company, later became a co-developer of the drug through a development agreement.

On October 9, 2014, Amgen’s BiTE® Immunotherapy Blinatumomab was granted FDA Priority Review Designation for Acute Lymphoblastic Leukemia. Then, on December 3, 2014, the FDA approved Blincyto (blinatumomab) for Precursor B-Cell Acute Lymphoblastic Leukemia.

Clofarabine, a purine nucleoside antimetabolite, is currently under investigation for its potential in cancer treatment. In the U.S. and Canada, it is sold under the name Clolar, while in Europe, Australia, and New Zealand, it is marketed as Evoltra.

Inotuzumab ozogamicin is a medication used to treat cancer. It works by targeting a specific protein called CD22, which is found on immature B-cell lymphocytes. By blocking the growth of tumor cells, the drug aims to restore normal blood counts and achieve complete remission from the disease.