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Publication Number
US-12150942-B2
Publication Date
2024-11-26
Expiration Date
Abstract
Compositions and methods for treating multiple myeloma (MM), acute myeloid lymphoma (AML) or a myeloproliferative disease (MPD) in a human patient in need thereof. The methods entail administering to the patient an effective amount of cerdulatinib.
Core Innovation
The invention relates to methods of treating acute myeloid leukemia (AML) or a myeloproliferative disease (MPD) in a human patient in need thereof by administering cerdulatinib or a pharmaceutically acceptable salt. The treatment is described using an effective amount within a daily range and with administration twice daily. Patient selection is further defined by the presence of an FGFR3 activation mutation and, in other aspects, by clinical prior-treatment history.
A problem being solved is the need for treating AML or an MPD in humans, including patients having an FGFR3 activation mutation and/or those who have relapsed or not responded to prior chemotherapy and have failed at least two prior therapies. The document describes defining eligibility criteria and regimens for such patients. It also describes excluding concurrent therapies in certain embodiments.
The document additionally frames cerdulatinib as an ATP-competitive reversible inhibitor targeting SYK/JAK pathway activity. Preclinical and pharmacokinetic/pharmacodynamic findings are described as supporting the approach, including induction of apoptosis and inhibition of proliferation in AML- and MM-related cell contexts, as well as pathway inhibition and marker changes. The disclosure also includes optional combination approaches through administration of a second agent, including classes such as P90RSK inhibitors and a listed set of chemotherapeutic agents.
Claims Coverage
Two independent claims are identified. Both claims cover methods of treating AML or MPD in a human patient with twice-daily cerdulatinib at an effective daily amount in the range of about 30 mg to about 80 mg, with distinct patient-selection criteria for an FGFR3 activation mutation versus prior-treatment failure/relapse.
Twice-daily cerdulatinib for FGFR3 activation mutation AML or MPD
Administering to a human patient in need thereof an effective amount of cerdulatinib (or a pharmaceutically acceptable salt) from about 30 mg to about 80 mg daily, wherein administration is twice daily, and wherein the patient has an FGFR3 activation mutation.
Twice-daily cerdulatinib for relapsed or chemotherapy-nonresponsive AML or MPD after at least two prior therapies
Administering to a human patient in need thereof an effective amount of cerdulatinib (or a pharmaceutically acceptable salt) from about 30 mg to about 80 mg daily, wherein administration is twice daily, wherein the patient has relapsed or not responded to a prior chemotherapy, and wherein the patient has failed at least two prior therapies.
Overall, the claim coverage centers on twice-daily cerdulatinib dosing within about 30 mg to about 80 mg daily for AML or MPD, with inventive patient-selection aspects specifying either FGFR3 activation mutation or relapsed/nonresponsive disease after failure of at least two prior therapies. Dependent claims further refine eligibility using lab thresholds and exclusions for concurrent therapies, and optionally define combination regimens via administration of a second agent.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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