Besponsa (inotuzumab ozogamicin)

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Besponsa (inotuzumab ozogamicin)

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Manufacturer Pfizer
Disease Acute Lymphoblastic Leukemia
Indication B-cell acute lymphoblastic leukemia (ALL)
Mode of Action CD22-directed antibody-drug conjugate (ADC) (targeted therapy)
Approval Status EMA approved (EU); FDA approved (USA)
Strength 1 mg

Who is Besponsa (inotuzumab ozogamicin) for?

Besponsa (inotuzumab ozogamicin) is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) [1][2].

Besponsa (inotuzumab ozogamicin) recommended dose

Complete information about Besponsa (inotuzumab ozogamicin) dosage and administration can be found here [1][2].
Prior to all infusions, patients need to be pre-medicated with a corticosteroid, antipyretic, and antihistamine [1][2].
The standard dosage is:
  • Cycle 1 (21 days):
    • Day 1: 0.8 mg/m2
    • Day 8 : 0.5 mg/m2
    • Day 15: 0.5 mg/m2
Cycle 1 is 3 weeks in duration but may be extended to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.
  • Following cycles (28 days)
    • for patients who have achieved CR or CRi
      • Day 1: 0.5 mg/m2
      • Day 8: 0.5 mg/m2
      • Day 15: 0.5 mg/m2
    • for patients who have not achieved CR or CRi
      • Day 1: 0.8 mg/m2
      • Day 8: 0.5 mg/m2
      • Day 15: 0.5 mg/m2
Besponsa (inotuzumab ozogamicin) is given as an infusion into a vein lasting for at least one hour. The infusions are given on days 1, 8 and 15 of a 3 or 4-week treatment cycle. The treatment may be interrupted or the dose may be reduced if the patient develops certain serious side effects [3].
Patients in whom Besponsa (inotuzumab ozogamicin) works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment. Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment. In patients who do not respond to treatment, Besponsa (inotuzumab ozogamicin) should be stopped after 3 cycles [3].
Consult your treating doctor for personalised dosing.

What is Besponsa (inotuzumab ozogamicin) and how does it work?

Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC) used to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) [1][2].
The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule — N-acetyl-gamma-calicheamicin dimethylhydrazide — a cytotoxic agent that once activated provokes the death of cancer cells. The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells. Once attached, the medicine is taken up by the cell where calicheamicin becomes active, causing breaks in the cell’s DNA and thereby killing the cancer cell [3].

Is Besponsa (inotuzumab ozogamicin) approved?

Besponsa (inotuzumab ozogamicin) was approved by:
  • EMA (EU) on June 29, 2017 [3]
  • FDA (USA) on August 17, 2017 [4]
as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL) [1][2].
The approvals were based on a randomized (1:1), open-label, international, multicenter study (INO-VATE ALL (NCT01564784)) involving a total of 326 patients. The efficacy of was established on the basis of results in the initial 218 randomized patients, which were later on confirmed with those seen in all 326 randomized patients [2].
The results of the first 218 patients showed that after at least 2 cycles of treatment, 80.7 % (88 out of 109) of patients receiving Besponsa (inotuzumab ozogamicin) responded to treatment compared with 29 % (32 out of 109) of patients receiving other chemotherapy. Of the 88 responding patients 39 achieved a complete remission (CR) and 49 a complete remission with incomplete hematologic recovery (CRi) [2][1]. Patients who responded to treatment could proceed to have a stem cell transplant [1].
References
[1] Summary of Product Characteristics [EMA]: Besponsa (inotuzumab ozogamicin), Pfizer, July 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004119/WC500231261.pdf
[2] Summary of Product Characteristics [FDA]: Besponsa (inotuzumab ozogamicin), Pfizer, Aug 2017.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf
[3] EMA. Human Medicines: Besponsa (inotuzumab ozogamicin), 13/07/2017 (last update: 13/07/2017), cited on 27/09/2017.
http://www.ema.europa.eu/ema/index.jsp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

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