Another treatment
opportunity
FDA-approved MARQIBO
®
(vinCRIStine sulfate LIPOSOME injection)
For the treatment of adult patients with Philadelphia chromosome–
negative (Ph–) acute lymphoblastic leukemia (ALL) in second
or greater relapse or whose disease has progressed following
2 or more anti-leukemia therapies. This indication is based on
overall response rate. Clinical benefit such as improvement in
overall survival has not been verified.
• 15.4% (10/65) overall response rate in patients who received multiple prior
therapies (4.6% CR + 10.8% CRi) (95% CI 7.6–26.5)1
− 100% had previously received non-liposomal (standard) vincristine
− 48% had undergone prior hematopoietic stem cell transplant (HSCT)
− 51% had received 3 or more prior therapies
− 45% were refractory to their immediate prior therapy
− 85% had precursor B-cell ALL and 15% had precursor T-cell ALL
− 100% were ineligible for immediate HSCT at enrollment
− 34% had not received asparaginase products
• Neutropenia, thrombocytopenia, or anemia may occur. Monitor blood counts prior to
each dose. Consider dose modification or reduction as well as supportive care measures
if Grade 3 or 4 myelosuppression develops
• Anticipate, monitor for, and manage tumor lysis syndrome
• A prophylactic bowel regimen should be instituted with MARQIBO to prevent constipation,
bowel obstruction, and/or paralytic ileus
• Severe fatigue can occur requiring dose delay, reduction, or discontinuation of MARQIBO
• Fatal liver toxicity and elevated levels of aspartate aminotransferase have occurred.
Monitor liver function and modify or interrupt dosing for hepatic toxicity
• MARQIBO can cause fetal harm. Advise women of potential risk to fetus
Adverse Events
• The most commonly reported adverse reactions (incidence >30%) in clinical studies
− 28 days (95% CI 7, 36) based on the first date of CR or CRi to the date of the
include constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral
last available histologic assessment of the same response (n=8)
neuropathy )Aɥ