# US 11,896,596 B2 · Methods of treating B-cell proliferative disorder > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,596 B2 - Document ID: US11896596B2 - Status: Granted - Kind: B2 - Application number: 18/206,290 - Filed: 2023-06-06 - Published: 2023-12-14 - Granted: 2024-02-13 - Earliest claimed: 2022-06-08 - Assignees: BeiGene Switzerland GmbH - Applicants: BeiGene Switzerland GmbH - Inventors: Jason Paik; Tommi Salmi; Ying Ou; Motohisa Takai - Web page: https://patentgrep.com/patent/US11896596B2 ## CPC - A61K 31/52: Purines, e.g. adenine - A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 35/00: Antineoplastic agents - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Provided herein is a method of treating a patient having a B-cell proliferative disorder, the method comprising administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, wherein the patient is characterized by being administered with a moderate CYP3A inducer. In one embodiment, zanubrutinib is administered at a dose of about 320 mg twice a day, or at a total daily dose of about 640 mg. ## Claims ### Claim 1 A method of treating or delaying progression of a B-cell proliferative disorder in a patient receiving a moderate CYP3A inducer, the method comprising concomitantly administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a dose of about 320 mg twice a day, and the moderate CYP3A inducer, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or follicular lymphoma (FL); and the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin. ### Claim 2 (depends on 1) The method of claim 1, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL). ### Claim 3 (depends on 2) The method of claim 2, wherein the moderate CYP3A inducer is rifabutin. ### Claim 4 (depends on 1) The method of claim 1, wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL). ### Claim 5 (depends on 1) The method of claim 1, wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM). ### Claim 6 (depends on 1) The method of claim 1, wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL). ### Claim 7 (depends on 1) The method of claim 1, wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL). ### Claim 8 (depends on 1) The method of claim 1, wherein the moderate CYP3A inducer is rifabutin. ### Claim 9 A method of treating or delaying progression of a B-cell proliferative disorder in a patient, the method comprising selecting the patient who is being treated with a moderate CYP3A inducer; and concomitantly administering to the selected patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a dose of about 320 mg twice a day, and the moderate CYP3A inducer, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or diffuse large B-cell lymphoma (DLBCL). ### Claim 10 (depends on 9) The method of claim 9, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL). ### Claim 11 (depends on 9) The method of claim 9, wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL). ### Claim 12 (depends on 9) The method of claim 9, wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM). ### Claim 13 (depends on 9) The method of claim 9, wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL). ### Claim 14 (depends on 9) The method of claim 9, wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL). ### Claim 15 (depends on 9) The method of claim 9, wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin. ### Claim 16 (depends on 15) The method of claim 15, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL). ### Claim 17 (depends on 16) The method of claim 16, wherein the moderate CYP3A inducer is rifabutin. ### Claim 18 A method of treating or delaying progression of a B-cell proliferative disorder in a patient receiving a moderate CYP3A inducer, the method comprising assessing the patient as to whether the patient can avoid being treated with the moderate CYP3A inducer; selecting the patient who cannot avoid being treated with the moderate CYP3A inducer; and concomitantly administering to the selected patient zanubrutinib, or a pharmaceutically acceptable salt thereof, at a dose of about 320 mg twice a day, and the moderate CYP3A inducer, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), or diffuse large B-cell lymphoma (DLBCL). ### Claim 19 (depends on 18) The method of claim 18, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL). ### Claim 20 (depends on 18) The method of claim 18, wherein the B-cell proliferative disorder is small lymphocytic lymphoma (SLL). ### Claim 21 (depends on 18) The method of claim 18, wherein the B-cell proliferative disorder is Waldenström macroglobulinemia (WM). ### Claim 22 (depends on 18) The method of claim 18, wherein the B-cell proliferative disorder is mantle cell lymphoma (MCL). ### Claim 23 (depends on 18) The method of claim 18, wherein the B-cell proliferative disorder is marginal zone lymphoma (MZL). ### Claim 24 (depends on 18) The method of claim 18, wherein the moderate CYP3A inducer is rifabutin, bosentan, efavirenz, etravirine, modafinil, phenobarbital or nafcillin. ### Claim 25 (depends on 24) The method of claim 24, wherein the B-cell proliferative disorder is chronic lymphocytic leukemia (CLL). ### Claim 26 (depends on 25) He method of claim 25, wherein the moderate CYP3A inducer is rifabutin. ### Claim 27 (depends on 9) The method of claim 9, wherein the B-cell proliferative disorder is diffuse large B-cell lymphoma (DLBCL). ### Claim 28 (depends on 18) The method of claim 18, wherein the B-cell proliferative disorder is diffuse large B-cell lymphoma (DLBCL).