IP Library › Granted Patent US 12,318,384
Granted Patent B2
US 12,318,384 · App. 17/727,455 · Granted Jun 3, 2025

Methods of treatment

Inventors: Sundar Srinivasan (Corona Del Mar, CA); Christina Chow Wallen (Seattle, WA)
Assignee: BOW RIVER LLC
A61K31/496A61K9/0019A61K9/0053A61K9/0056A61K9/0078A61K9/0095A61K9/08A61K9/10A61K9/2004A61K9/4841A61K31/00A61K31/397A61K31/407A61K31/4468A61K31/454A61K31/4745A61K31/497A61K31/498A61K31/4995A61K31/502A61K31/506A61K31/519A61K31/5383A61K31/5395A61P25/16A61P25/18A61P35/02A61P35/04
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Quick Facts
Patent No.
US 12,318,384
App. No.
17/727,455
Granted
Jun 3, 2025
Kind
B2
Abstract

The present disclosure provides for methods of treating a patient with a CYP3A4 substrate drug, wherein the patient is treated with posaconazole. In some embodiments, the patient stops posaconazole treatment, waits for at least 2 days, and then is treated with the CYP3A4 substrate drug as soon as it is safe to do so. In some embodiments, treatment with the CYP3A4 substrate drug is delayed for about 2-42 days after stopping posaconazole. In some embodiments, the patient is treated with a reduced dose of the CYP3A4 substrate drug for about 2-42 days.

Claims (38)

1. A method of treating advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, HER2-negative breast cancer, metastatic pancreatic cancer, or metastatic castration-resistant prostate cancer, in a patient in need of treatment with a CYP3A4 substrate drug, wherein the patient is treated with a strong CYP3A4 inhibitor, comprising:

(a) stopping the strong CYP3A4 inhibitor treatment;

(b) delaying administering, for about 3 to 5 half-lives of the strong CYP3A4 inhibitor after stopping the strong CYP3A4 inhibitor treatment, a dose of the CYP3A4 substrate drug that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor; and then

(c) administering the dose of the CYP3A4 substrate drug that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor,

wherein the CYP3A4 inhibitor is posaconazole and the CYP3A4 substrate drug is olaparib.

2. The method of claim 1 , wherein the ovarian, fallopian tube, or primary peritoneal cancer is germline BRCA-mutated (gBRCAm) advanced ovarian, fallopian tube, or primary peritoneal cancer.

3. The method of claim 1 , wherein the HER2-negative breast cancer is germline BRCA-mutated (gBRCAm) HER2-negative breast cancer.

4. The method of claim 1 , wherein the patient is not obese.

5. The method of claim 1 , wherein the patient has at least one characteristic selected from the group consisting of the following:

i) BMI of at least about 35;

ii) waist size greater than about 42 inches;

iii) % body fat greater than about 40%;

iv) total body fat greater than about 40 kg; and

v) medically diagnosed as obese.

6. The method of claim 1 , wherein said delaying in step (b) is 3 half-lives of the strong CYP3A4 inhibitor after stopping the strong CYP3A4 inhibitor in step (a).

7. The method of claim 1 , wherein said delaying in step (b) is 4 half-lives of the strong CYP3A4 inhibitor after stopping the strong CYP3A4 inhibitor in step (a).

8. The method of claim 1 , wherein said delaying in step (b) is 5 half-lives of the strong CYP3A4 inhibitor after stopping the strong CYP3A4 inhibitor in step (a).

9. The method of claim 1 , wherein the dose of olaparib administered in step (c) is a total daily dose of 600 mg.

10. The method of claim 1 , wherein the dose of olaparib in step (c) is 300 mg, administered twice daily.

11. The method of claim 1 , wherein the patient is administered a total daily dose of olaparib of 200 mg concurrently with posaconazole prior to stopping posaconazole treatment in step (a).

12. The method of claim 1 , wherein the patient is administered 100 mg of olaparib concurrently with posaconazole prior to stopping posaconazole treatment in step (a).

13. The method of claim 1 , wherein the patient is administered a total daily dose of olaparib of 200 mg in step (b) prior to administering the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor in step (c).

14. The method of claim 1 , wherein the patient is administered 100 mg of olaparib in step (b) prior to administering the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor in step (c).

15. The method of claim 1 , wherein the patient is treated for epithelial ovarian, fallopian tube, or primary peritoneal cancer; HER2-negative breast cancer.

16. The method of claim 1 , wherein the patient is treated for metastatic pancreatic cancer.

17. The method of claim 1 , wherein the patient is treated for metastatic castration-resistant prostate cancer.

18. The method of claim 1 , wherein concurrently with posaconazole and prior to stopping posaconazole treatment in step (a), the patient is administered a dose of olaparib that is less than the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor.

19. The method of claim 1 , wherein in step (b) the patient is administered a dose of olaparib that is less than the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor.

20. The method of claim 1 , wherein concurrently with posaconazole and prior to stopping posaconazole treatment in step (a), the patient is administered about ⅓ of the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor.

21. The method of claim 19 , wherein in step (b) the patient is administered about ⅓ of the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor.

22. The method of claim 1 , wherein the patient is administered 100 mg of olaparib twice daily concurrently with posaconazole prior to stopping posaconazole treatment in step (a).

23. The method of claim 1 , wherein the patient is administered 100 mg of olaparib twice daily in step (b) prior to administering the dose of olaparib that the patient would have received based on the age and condition of the patient if the patient had not been treated with the strong CYP3A4 inhibitor in step (c).

24. The method of claim 22 , wherein the patient is treated for epithelial ovarian, fallopian tube or primary peritoneal cancer, or HER2-negative breast cancer.

25. The method of claim 22 , wherein the patient is treated for metastatic pancreatic cancer.

26. The method of claim 22 , wherein the patient is treated for metastatic castration-resistant prostate cancer.

27. The method of claim 23 , wherein the patient is treated for epithelial ovarian, fallopian tube or primary peritoneal cancer, or HER2-negative breast cancer.

28. The method of claim 23 , wherein the patient is treated for metastatic pancreatic cancer.

29. The method of claim 23 , wherein the patient is treated for metastatic castration-resistant prostate cancer.

Continuity (12)
Continuation 17700947 · Mar 22, 2022
Continuation 17469628 · Sep 8, 2021
Continuation 17407440 · Aug 20, 2021
Continuation 17244065 · Apr 29, 2021
Continuation 17150467 · Jan 15, 2021
Continuation 17099298 · Nov 16, 2020
Continuation 17082902 · Oct 28, 2020
Continuation 16408931 · May 10, 2019
Division 16191351 · Nov 14, 2018
Continuation In Part 15596585 · May 16, 2017
Continuation In Part 15596585 · May 16, 2017
Related Publication 20220249459A1 · Aug 11, 2022
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NEXAVAR (sorafenib), Tablets: 200 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Nov. 2013 (Nov. 2013), Initial U.S. Approval: 2005, Ref… [cited by applicant]
NIZORAL® (ketoconazole)Label; Patient Information approved by the U.S. Food and Drug Administration, Reference ID: 3458324, Copyright 2014 Janssen Pharmaceuticals, Inc., New Jersey, USA, Revised Feb. 2014, 23 pages. [cited by applicant]
NOXAFIL® (posaconazole), Highlights of Prescribing Information, Label; Patient Information approved by the U.S. Food and Drug Administration; Copyright 2006, 2010, 2013, 2014 Merck Sharp & Dohme Corp., a subsidiary of M… [cited by applicant]
NOXAFIL® (posaconazole) injection 18 mh/mL; delayed-release tablets 100mg; oral suspension 40 mg/mL, Highlights of Prescribing Information, FDA Label; Revised Nov. 2015 (Nov. 2015), Reference ID: 3847805, Initial U.S. A… [cited by applicant]
ODOMZO® (sonidegib), Capsules: 200 mg capsules, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: May 2016 (May 2016), Initial U.S. Approval: 2… [cited by applicant]
ONIVYDE™ (irinotecan liposome injection), for intravenous use, Injection: 43 mg/10 mL single dose vial, Revised: Oct. 2015 (Oct. 2015), Initial U.S. Approval: 1996, Reference ID: 3836766, Manufactured for: Merrimack Pha… [cited by applicant]
ORAVIG® (miconazole), Highlights of Prescribing Information, Label; Patient Information approved by the U.S. Food and Drug Administration; Copyright 2012 Praelia Pharmaceuticals, Inc., North Carolina, USA (Manufactured … [cited by applicant]
Payne and Hall, “Dosing of antifungal agents in obese people.” Expert Review of Anti-infective Therapy (2016); 14(2): 257-267. [cited by applicant]
POMALYST® (pomalidomide), Capsules: 1 mg, 2 mg, 3 mg, and 4 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Jun. 2016 (Jun. 2016), Initia… [cited by applicant]
RANEXA® (ranolazine), Extended-release tablets: 500 mg, Highlights of Prescribing Information, Label; Patient Information approved by the U.S. Food and Drug Administration; Copyright 2016 Gilead Sciences, Inc., Foster C… [cited by applicant]
RANEXA® (Ranolazine), Ranexa 375 mg prolonged-release tablets, Ranexa 500 mg, and Ranexa 750 mg prolonged-release tablets, Patient Information, Label and Package Leaflet, 62 pages. European Medicines Agency, First Publi… [cited by applicant]
Roberts, et al., “Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia”, N Engl J Med (Jan. 2016); 374: 311-322. [cited by applicant]
[cited by applicant]
RYDAPT® (midostaurin) Capsules: 25 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Apr. 2017 (Apr. 2017), Initial U.S. Approval: 2017, Re… [cited by applicant]
Sandherr and Maschmeyer, “Pharmacology and metabolism of voriconazole and posaconazole in the treatment of invasive aspergillosis—review of the literature.” European Journal of Medical Research (2011); 16: 139-144. [cited by applicant]
SPORANOX® (itraconazole), Label; Patient Information approved by the U.S. Food and Drug Administration, Reference ID: 4071289, Copyright 2001 Janssen Pharmaceutical Companies, New Jersey, USA, Revised Mar. 2017, 40 page… [cited by applicant]
STIVARGA® (regorafenib), Tablets: 40 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Apr. 2017 (Apr. 2017), Initial U.S. Approval: 2012, … [cited by applicant]
SUTENT® (sunitinib malate), Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Apr. 2015 (Apr. 2015), … [cited by applicant]
SUTENT® (sunitinib malate), Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: May 2019 (May 2019), In… [cited by applicant]
Ta, C., et al., “Predicting Interactions with PDE5 Inhibitors.” Pharmacy Times (2005); pp. 16 and 28, 2 pages. [cited by applicant]
TACROLIMUS, Capsules RX only, Prescribing Information / Medication Guide / Package Insert / Label (May 27, 2009), Iss May 2009, Manufactured in India by Sandoz Private Limited for Sandoz Inc; Princeton NJ 08540, USA, 4 … [cited by applicant]
TAFINLAR® (dabrafenib) Capsules: 50 mg, 75 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Jun. 2016 (Jun. 2016), Initial U.S. Approval: … [cited by applicant]
TAFINLAR® (dabrafenib) Capsules: 50 mg, 75 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: May 2018 (May 2018), Initial U.S. Approval: 20… [cited by applicant]
TARCEVA® (erlotinib), Highlights of Prescribing Information, Label; Patient Information; NDA021743, Copyright 2016 Astellas Pharma US, Inc., and Genentech, Inc., Initial U.S. Approval: 2004, Revised Oct. 2016, 29 pages. [cited by applicant]
TARCEVA® (erlotinib) Tablets: 25 mg, 100 mg, and 150 mg, Label; Highlights of Prescribing Information, Revised: Oct. 2016 (Oct. 2016), Initial U.S. Approval: 2004, Reference ID: 4000318, Manufactured for: OSI Pharmaceut… [cited by applicant]
TARCEVA® Prescribing Information, published 2010. (Year: 2010), 24 pages. [cited by applicant]
TASIGNA® (nilotinib), 150 mg and 200 mg hard capsules, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Feb. 2017 (Feb. 2017), Initial U.S. Ap… [cited by applicant]
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry. “E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs.” (Oct… [cited by applicant]
VENCLEXTA™ (venetoclax) tablets, Highlights of Prescribing Information, FDA Label, Insert and Packaging, Tablets: 10 mg, 50 mg, 100 mg; Revised: Sep. 2018 (Sep. 2018), Initial U.S. Approval: 2016, Reference ID: 4316460,… [cited by applicant]
VENCLEXTA™ (venetoclax) tablets, Highlights of Prescribing Information, FDA Label, Tablets: 10 mg, 50 mg, 100 mg; Issued: Apr. 2016 (Apr. 2016), Initial U.S. Approval: 2016, Reference ID: 3915259, Manufactured and Marke… [cited by applicant]
VENCLEXTA™ (venetoclax) tablets, Prescribing Information, Tablets: 10 mg, 50 mg, 100 mg; Initial U.S. Approval: Apr. 2016 (Apr. 2016), Revised Jun. 2018 (Jun. 2018), Reference ID: 4275193, Manufactured and Marketed by: … [cited by applicant]
VERZENIO™ (abemaciclib) Tablets: 50 mg, 100 mg, 150 mg, and 200 mg, for oral use, Highlights of Prescribing Information, Label; Patient Information; Revised: Feb. 2018 (Feb. 2018), Initial U.S. Approval: 2017, Reference… [cited by applicant]
VERZENIO™ (abemaciclib), Tablets: 50 mg, 100 mg, 150 mg, and 200 mg; Highlights of Prescribing Information, Label; Patient Information approved by the U.S. Food and Drug Administration, Initial U.S. Approval: 2017; Revi… [cited by applicant]
VESIcare® (solifenacin succinate), Highlights of Prescribing Information, Label; Patient Information; NDA021518, Astellas Pharma US, Inc., Initial U.S. Approval: 2004, Revised Mar. 2017, 22 pages. [cited by applicant]
VESIcare® (solifenacin succinate), Prescribing Information, Revised: Apr. 2010, published 2009, 16 pages. [cited by applicant]
VFEND® (voriconazole), Highlights of Prescribing Information, Label; Patient Information approved by the U.S. Food and Drug Administration, Roerig, Division of Pfizer Inc., New York, NY, Initial U.S. Approval: 2002, Rev… [cited by applicant]
VITRAKVI® (larotrectinib) capsules, VITRAKVI® (larotrectinib) oral solution, Capsules: 25 mg, 100 mg, Oral Solution: 20 mg/mL, Revised: Nov. 2018 (Nov. 2018), Initial U.S. Approval: 2018, Reference ID: 4354324, Manufact… [cited by applicant]
VOTRIENT (pazopanib), Highlights of Prescribing Information 200 mg tablets (3), Initial U.S. Approval: 2009, Reference ID: 3823458, Revised Sep. 2015, 27 pages. [cited by applicant]
VOTRIENT (pazopanib), Tablets: 200 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Aug. 2016 (Aug. 2016), Initial U.S. Approval: 2009, Re… [cited by applicant]
VRAYLAR® (cariprazine) Capsules: 1.5 mg, 3 mg, 4.5 mg, and 6 mg, Label; Highlights of Prescribing Information, Revised: Nov. 2017 (Nov. 2017), Initial U.S. Approval: 2015, Reference ID: 4179057, Licensed from Gedeon Ric… [cited by applicant]
XALKORI (crizotinib) Capsules: 250 mg and 200 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Apr. 2017 (Apr. 2017), Initial U.S. Approva… [cited by applicant]
XARELTO® (rivaroxaban), Tablets: 2.5 mg, 10 mg, 15 mg, and 20 mg, Highlights of Prescribing Information / Package Insert / Label/ Full Prescribing Information, Initial U.S. Approval: 2011, Revised: Jan. 2019 (Jan. 2019)… [cited by applicant]
XELJANZ® (tofacitinib) tablets, for oral use, XELJANZ® XR (tofacitinib) extended-release tablets for oral use, XELJANZ Tablets: 5 mg, 10 mg tofacitinib, XELJANZ XR Tablets: 11 mg tofacitinib, Highlights of Prescribing I… [cited by applicant]
YONDELIS (trabectedin), injection, for intravenous use; 1 mg sterile lyophilized powder in a single-dose vial, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Adminis… [cited by applicant]
ZELBORAF® (vemurafenib), Tablets: 240 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Apr. 2017 (Apr. 2017), Initial U.S. Approval: 2011,… [cited by applicant]
ZORTRESS® (everolimus), Highlights of Prescribing Information, Label; Patient Information; NDA021560, Novartis Pharmaceuticals Corporation, Initial U.S. Approval: 2010, Revised Oct. 2016, 42 pages. [cited by applicant]
Extended European Search Report for European Application No. 22163202.9 dated Sep. 15, 2022, 14 pages. [cited by applicant]
Greenblatt, et al., “Declaration of Dr. David J. Greenblatt”, Jun. 3, 2020, Retrieved from the Internet: URL:https://register.epo.org/application?number=EP17897227&lng=en&tab=doclist, 15 pages. [cited by applicant]
LYNPARZA® (olaparib), Capsules: 150 mg, 100 mg, Label; Highlights of Prescribing Information, Medication Guide approved by the U.S. Food and Drug Administration; Revised: May 2020 (May 2020), Initial U.S. Approval: 2014… [cited by applicant]
VENCLEXTA™ (venetoclax) tablets, Highlights of Prescribing Information, FDA Label, Tablets: 10 mg, 50 mg, 100 mg; Revised: May 2019 (May 2019), Initial U.S. Approval: 2016, Reference ID: 4433568, Manufactured and Market… [cited by applicant]
BOSULIF® (bosutinib) Tablets: 100 mg, 400 mg, and 500 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Oct. (Oct. 2018), Initial U.S. Appr… [cited by applicant]
European Application No. 18926463.3, Response dated and filed Aug. 14, 2023, 17 pages. [cited by applicant]
IMBRUVICA® (ibrutinib), Capsules: 70 mg and 140 mg, Tablets: 140 mg, 280 mg, 420 mg, and 560 mg; Highlights of Prescribing Information, Label; Patient Information approved by the U.S. Food and Drug Administration, Initi… [cited by applicant]
JAKAFI® (ruxolitinib), Tablets: 5 mg, 10 mg, 15 mg, 20 mg and 25 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Oct. 2018 (Oct. 2018), I… [cited by applicant]
NERLYNX (neratinib), Tablets: 40 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Jun. 2018 (Jun. 2018), Initial U.S. Approval: 2017, Refe… [cited by applicant]
SPRYCEL® (dasatinib), Tablets: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Nov. 2017 (Nov… [cited by applicant]
STIVARGA® (regorafenib), Tablets: 40 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Jun. 2018 (Jun. 2018), Initial U.S. Approval: 2012, … [cited by applicant]
SUTENT® (sunitinib malate), Capsules: 12.5 mg, 25 mg, 37.5 mg, 50 mg, Label; Highlights of Prescribing Information, Medication Guide approved by the U.S. Food and Drug Administration; Revised: Nov. 2017 (Nov. 2017), Ini… [cited by applicant]
TASIGNA® (nilotinib), Capsules: 50 mg, 150 mg and 200 mg, Label; Highlights of Prescribing Information, Medication Guide approved by the U.S. Food and Drug Administration; Revised: Jul. 2018 (Jul. 2018), Initial U.S. Ap… [cited by applicant]
TIBSOVO® (ivosidenib tablets), Tablets: 250 mg, Label; Highlights of Prescribing Information, Medication Guide approved by the U.S. Food and Drug Administration; Revised: Jul. 2018 (Jul. 2018), Initial U.S. Approval: 20… [cited by applicant]
VOTRIENT (pazopanib), Tablets: 200 mg, Label; Highlights of Prescribing Information, Medication Guide approved by the U.S. Food and Drug Administration; Revised: May 2017 (May 2017), Initial U.S. Approval: 2009, Referen… [cited by applicant]
XALKORI® (crizotinib) Capsules: 250 mg and 200 mg, Label; Highlights of Prescribing Information, Patient Information approved by the U.S. Food and Drug Administration; Revised: Feb. 2018 (Feb. 2018), Initial U.S. Approv… [cited by applicant]
ZELBORAF® (vemurafenib), Tablets: 240 mg, Label; Highlights of Prescribing Information, Medication Guide approved by the U.S. Food and Drug Administration; Revised: Nov. 2017 (Nov. 2017), Initial U.S. Approval: 2011, Re… [cited by applicant]
Communication under Rule 71(3) EPC for European Application No. EP18926463.3, by Bow River LLC, mailed Apr. 5, 2024, 221 pages. [cited by applicant]
Co-pending U.S. Appl. No. 18/600,372, inventors Srinivasan; Sundar et al., filed Mar. 8, 2024. [cited by applicant]
European Application No. 18926463.3, Response, by Bow River LLC, dated and filed Feb. 21, 2024, 41 pages. [cited by applicant]
European Application No. 18926463.3, Response, by Bow River LLC, dated and filed Mar. 19, 2024, 343 pages. [cited by applicant]
Result of Consultation, by Bow River LLC, for European Application No. EP18926463.3 dated Mar. 14, 2024, 3 pages. [cited by applicant]
Result of Consultation, by Bow River LLC, for European Application No. EP18926463.3 dated Mar. 20, 2024, 3 pages. [cited by applicant]
Cited By (1)
US 12,453,730