Claims for Patent: 10,159,675

Summary for Patent: 10,159,675

Title:	Cycling therapy using 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione
Abstract:	Provided herein are methods of treating, preventing and/or managing cancer, including lymphoma, which comprise administering to a patient 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, or an enantiomer or a mixture of enantiomers thereof, or a pharmaceutically acceptable salt, solvate, hydrate, co-crystal, clathrate, or polymorph thereof in a cyclic therapy regimen.
Inventor(s):	Hagner; Patrick (Sparta, NJ), Gandhi; Anita (Bernardsville, NJ), Pourdehnad; Michael (San Francisco, CA)
Assignee:	Celgene Corporation (Summit, NJ)
Application Number:	15/367,117
Patent Claims:	1. A method for treating, managing, and/or ameliorating lymphoma, while reducing an adverse effect associated with such treating, managing, and/or ameliorating, said method comprising administering to a patient in need thereof an effective amount of compound 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione, which has the following structure: ##STR00004## or a pharmaceutically acceptable salt, solvate, hydrate, polymorph, stereoisomer, tautomer or racemic mixture thereof, wherein the compound is administered to said subject in a cycling therapy, said cycling therapy comprising: an administration period of 5 days followed by a rest period of 2 days. 2. The method of claim 1, wherein the compound is a solvate of 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione. 3. The method of claim 1, wherein the compound is a hydrate of 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione. 4. The method of claim 1, wherein the compound is a pharmaceutically acceptable salt of 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione. 5. The method of claim 1, wherein the compound is 3-(5-amino-2-methyl-4-oxo-4H-quinazolin-3-yl)-piperidine-2,6-dione. 6. The method of claim 1, wherein the adverse effect comprises neutropenia. 7. The method of claim 1, wherein the compound is administered orally. 8. The method of claim 1, wherein the compound is administered at a dose of about 1 mg to about 5 mg. 9. The method of claim 8, wherein the dose is about 3 mg or about 4mg. 10. The method of claim 8, wherein the dose is about 4 mg. 11. The method of claim 8, wherein the dose is about 3 mg. 12. The method of claim 1, wherein the cycling therapy is repeated 2 to 6times. 13. The method of claim 1, wherein the method further comprises co-administering a second therapeutic agent. 14. The method of claim 13, wherein said second therapeutic agent is selected from oblimersen, GM-CSF, G-CSF, SCF, EPO, rituximab, obinutuzumab, tositumomab,131I tositumomab, 90Y ibritumomab, 111I ibritumomab, ofatumumab, brentuximab vedotin, nelarabine, cyclophosphamide, chlorambucil, bendamustine, carmustine, ifosfamide, prednisone, dexamethasone, cisplatin, carboplatin, oxaliplatin, fludarabine, pentostatin, cladribine, cytarabine, gemcitabine, methotrexate, pralatrexate, vincristine, vinblastine sulfate, doxorubicin, mitoxantrone, etoposide, belinostat, bortezomib, denileukin diftitox, ibrutinib, idelalisib, intron A, recombinant interferon Alfa-2b, romidepsin, lenalidomide, mechlorethamine hydrochloride, plerixafor, vorinostat, and bleomycin, or a combination thereof. 15. The method of claim 1, wherein the lymphoma is non-Hodgkin lymphoma. 16. The method of claim 1, wherein the lymphoma is diffuse large B-cell lymphoma. 17. The method of claim 16, wherein the diffuse large B-cell lymphoma is activated B-cell type. 18. The method of claim 16, wherein the diffuse large B-cell lymphoma is germinal center B-cell type. 19. The method of claim 16, wherein the diffuse large B-cell lymphoma is of unclassified cell of origin. 20. The method of claim 16, wherein the diffuse large B-cell lymphoma is relapsed or refractory. 21. The method of claim 1, wherein the lymphoma is mantle cell lymphoma. 22. The method of claim 1, wherein the lymphoma is relapsed or refractory.

Details for Patent 10,159,675

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	June 04, 1986		2035-12-02
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132			2035-12-02
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	Injection	103132			2035-12-02
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997		2035-12-02