Granted Patent
B2
US 12,636,300 · App. 18/181,467 · Granted May 26, 2026
Methods of treatment and maintenance therapy for bladder cancer using gemcitabine
Assignee:
Janssen Biotech, Inc.
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Abstract
Provided are methods of treating urothelial carcinomas of the lower tract comprising administering comprising administering gemcitabine continuously and locally to the bladder of an individual in an induction therapy and/or maintenance therapy.
Claims (46)
1 . A method of treating bladder cancer in an individual comprising
a) an induction phase comprising
i) placing a first intravesical device comprising about 225 mg of gemcitabine into the bladder of the individual, and
removing the first intravesical device after about three weeks,
wherein the first intravesical device releases gemcitabine continuously into urine in the bladder of the individual during a first induction phase delivery period of at least one week;
ii) placing a second intravesical device comprising about 225 mg of gemcitabine into the bladder of the individual about three weeks after the first intravesical device is placed into the bladder, and
removing the second intravesical device after about three weeks,
wherein the second intravesical device releases gemcitabine continuously into urine in the bladder of the individual during a second induction phase delivery period of at least one week,
wherein the first intravesical device is removed before the second intravesical device is placed into the bladder of the individual;
iii) placing a third intravesical device comprising about 225 mg of gemcitabine into the bladder of the individual about three weeks after the second intravesical device is placed into the bladder, and
removing the third intravesical device after about three weeks,
wherein the third intravesical device releases gemcitabine continuously into urine in the bladder of the individual during a third induction phase delivery period of at least one week,
wherein the second intravesical device is removed before the third intravesical device is placed into the bladder of the individual;
iv) placing a fourth intravesical device comprising about 225 mg of gemcitabine into the bladder of the individual about three weeks after the third intravesical device is placed into the bladder, and
removing the fourth intravesical device after about three weeks, wherein the fourth intravesical device releases gemcitabine continuously into urine in the bladder of the individual during a fourth induction phase delivery period of at least one week,
wherein the third intravesical device is removed before the fourth intravesical device is placed into the bladder of the individual; and
b) a maintenance phase comprising about every three months
placing an intravesical device comprising about 225 mg of gemcitabine into the bladder of the individual, and
removing the intravesical device after about three weeks,
wherein the intravesical device releases gemcitabine continuously into urine in the bladder of the individual during a maintenance phase delivery period of at least one week.
2 . The method of claim 1 , wherein each induction phase delivery period and each maintenance phase delivery period is less than about three weeks.
3 . The method of claim 1 , wherein each induction phase delivery period and each maintenance phase delivery period is about one week to about three weeks.
4 . The method of claim 1 , wherein each induction phase delivery period and each maintenance phase delivery period is about two weeks to about three weeks.
5 . The method of claim 1 , wherein the gemcitabine is delivered at a dose of from about 5 mg/day to about 50 mg/day during each induction phase delivery period and each maintenance phase delivery period.
6 . The method of claim 1 , wherein the gemcitabine is delivered at a dose of from about 5 mg/day to about 10 mg/day during each induction phase delivery period and each maintenance phase delivery period.
7 . The method of claim 1 , wherein the concentration of gemcitabine in the urine is from about 1 μg/mL to about 30 μg/mL during each induction phase delivery period and each maintenance phase delivery period.
8 . The method of claim 7 , wherein the concentration of gemcitabine in the urine is from about 1 μg/mL to about 10 μg/mL during each induction phase delivery period and each maintenance phase delivery period.
9 . The method of claim 1 , wherein each intravesical device releases gemcitabine at a zero-order release rate, followed by a reduced, non-zero-order release rate over a decay period during each induction phase delivery period and each maintenance phase delivery period.
10 . The method of claim 1 , wherein the individual is ineligible for or has refused cisplatin-based chemotherapy.
11 . The method of claim 1 , wherein the individual is unfit for, ineligible for or has refused a radical cystectomy.
12 . The method of claim 1 , wherein the individual has muscle invasive bladder cancer.
13 . The method of claim 1 , wherein the individual has non-muscle invasive bladder cancer.
14 . The method of claim 1 , wherein the average concentration of gemcitabine in the urine is from about 5 μg/mL to about 20 μg/mL for about one week during each induction phase delivery period and each maintenance phase delivery period.
15 . The method of claim 1 , wherein each intravesical device comprises a housing configured for intravesical insertion; and a dosage form comprising the gemcitabine, wherein the housing holds the dosage form and is configured to release gemcitabine.
16 . The method of claim 15 , wherein the housing defines a reservoir, and the dosage form comprises a first unit contained within the reservoir and a second unit contained within the reservoir in a position distinct from the first unit, the first unit comprising gemcitabine and the second unit comprising a functional agent that facilitates in vivo release of the gemcitabine from the housing.
17 . The method of claim 1 , wherein the gemcitabine is released from the intravesical device by osmotic pressure.
18 . The method of claim 1 , wherein the gemcitabine is in a non-liquid form.
19 . The method of claim 18 , wherein the non-liquid form is selected from the group consisting of tablets, granules, powders, semisolids, capsules, and combinations thereof.
20 . The method of claim 16 , wherein the first unit comprises one or more gemcitabine mini-tablets and the second unit comprises one or more urea mini-tablets.
21 . The method of claim 16 , wherein the functional agent comprises urea.
22 . The method of claim 15 , wherein the housing is elastically deformable between a retention shape configured to retain the device in the individual's bladder and a deployment shape for passage of the device through the individual's urethra.
23 . The method of claim 15 , wherein the housing includes at least one orifice through which the gemcitabine is released.
24 . The method of claim 1 , wherein the induction phase comprises five or more induction phase delivery periods.
25 . The method of claim 1 , wherein the maintenance phase comprises about every three months:
placing an intravesical device comprising about 225 mg of gemcitabine into the bladder of the individual, and removing the intravesical device after about three weeks
for a total of 6 times.
Assignments (2)
MERGER
Recorded Apr 6, 2026
From: TARIS BIOMEDICAL LLC
To: JANSSEN BIOTECH, INC.
Reel/Frame 074284/0765 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 10, 2024
From: GIESING, DENNIS; CUTIE, CHRISTOPHER
To: TARIS BIOMEDICAL LLC
Reel/Frame 067060/0400 →
Continuity (4)
Provisional Application
62583394
· Nov 8, 2017
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