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Crizotinib is FDA approved for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.Limitations of Use: The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
Xalkori® Crizotinib
Denosumab is FDA approved for the prevention of skeletal-related events in patients with multiple myeloma.
Xgeva® Denosumab
Gilteritinib is a indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
Xospata® Gilteritinib
Selinexor is FDA approvedIn combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapyIn combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibodyFor the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.These indications are approved under accelerated approval based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Xpovio® Selinexor