IP Library Granted Patent US 11,260,057
Granted Patent B2
US 11,260,057 · App. 16/634,089 · Granted Mar 1, 2022

Combination comprising palbociclib and 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7] annulene-2-carboxylic acid and its use for the treatment of cancer

Inventors: Monsif Bouaboula (Paris, FR); Maysoun Shomali (Bridgewater, NJ); Fangxian Sun (Bridgewater, NJ)
Assignee: SANOFI
A61K31/519A61K31/40
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Quick Facts
Patent No.
US 11,260,057
App. No.
16/634,089
Granted
Mar 1, 2022
Kind
B2
Abstract

Herein are provided a combination of palbociclib and of 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid or a pharmaceutically acceptable salt thereof, a pharmaceutical composition containing such a combination, and the therapeutic uses thereof, in particular for the treatment of cancer, including breast cancer.

Claims (14)

1. A method of treating cancer comprising the administration to a subject in need thereof a combination of the compound 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and palbociclib.

2. The method according to claim 1 , wherein the cancer is breast cancer.

3. A pharmaceutical composition comprising a combination of the compound 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and palbociclib, and at least one pharmaceutically acceptable excipient.

4. The pharmaceutical composition according to claim 3 , wherein the compound and the palbociclib are present in amounts which provide therapeutic synergy.

5. The method according to claim 1 , wherein the compound and the palbociclib are administered simultaneously as a single pharmaceutical composition comprising the compound, the palbociclib and at least one pharmaceutically acceptable excipient.

6. The method according to claim 1 , wherein the compound and the palbociclib are administered in amounts which provide therapeutic synergy.

7. The method according to claim 1 , wherein the compound and the palbociclib are administered simultaneously as separate pharmaceutical compositions.

8. The method according to claim 1 , wherein the compound and the palbociclib are administered separately and spaced out over a period of time.

9. A pharmaceutical kit comprising:

(i) a first pharmaceutical composition comprising 6-(2,4-dichlorophenyl)-5-[4-[(3S)-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7H-benzo[7]annulene-2-carboxylic acid, or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient; and

(ii) a second pharmaceutical composition comprising palbociclib, and at least one pharmaceutically acceptable excipient;

wherein both pharmaceutical compositions (i) and (ii) are in separate compartments.

10. The method according to claim 2 , wherein the breast cancer is an estrogen-dependent breast cancer.

11. The method according to claim 2 , wherein the breast cancer is an estrogen-receptor positive breast cancer, or a metastasis thereof.

Assignments (2)
CHANGE OF ADDRESS Recorded Jul 3, 2024
From: SANOFI
To: SANOFI
Reel/Frame 068105/0767 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 14, 2021
From: SHOMALI, MAYSOUN; SUN, FANGXIAN; BOUABOULA, MONSIF
To: SANOFI
Reel/Frame 057788/0948 →