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Last Updated: March 29, 2024

Claims for Patent: 8,026,267


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Summary for Patent: 8,026,267
Title:Non-pegylated liposomal doxorubicin triple combination therapy
Abstract: The present invention relates to a method for treating metastatic breast cancer in an individual comprising administering to an individual in need thereof a dosing regimen which comprises administering to the individual nonpegylated liposomal doxorubicin, a taxane and a HER2/neu receptor antagonist, wherein the individual previously has been administered an anthracycline.
Inventor(s): Rozencweig; Marcel (Princeton, NJ), Goldfarb; Ronald H. (Guilford, CT), Forenza; Salvatore (Exton, PA)
Assignee: Sopherion Therapeutics, LLC (East Brunswick, NJ)
Application Number:12/880,037
Patent Claims:1. A method for treating metastatic breast cancer in an individual previously treated with an anthracycline comprising administering to an individual in need thereof a dosing regimen which comprises at least one 3-week long treatment cycle, and wherein said individual is administered nonpegylated liposomal doxorubicin at a dose level of from 30 mg/m.sup.2 to 75 mg/m.sup.2 on day 1 of each treatment cycle, paclitaxel at a dose level of from 50 mg/m.sup.2 to 250 mg/m.sup.2 on day 1 of each treatment cycle, and trastuzumab at a dose level of from 3 mg/kg to 5 mg/kg as a loading dose on day 1 of the first treatment cycle and every week thereafter at a dose level of from 1 mg/kg to 3 mg/kg, and wherein said individual previously has been administered an anthracycline.

2. A method according to claim 1, wherein said previous administration of anthracycline was for the treatment of cancer.

3. A method according to claim 2, wherein said previous administration of anthracycline was for the treatment of breast cancer.

4. A method according to claim 1, wherein said anthracycline previously administered to said individual is selected from the group consisting of doxorubicin, idarubicin, epirubicin and daunorubicin.

5. A method according to claim 4, wherein said anthracycline previously administered to said individual is doxorubicin.

6. A method according to claim 4, wherein the total amount of said anthracycline previously administered to said individual is from 7 mg/m.sup.2 to 450 mg/m.sup.2.

7. A method according to claim 6, wherein the total amount of said anthracycline previously administered to said individual is from 100 mg/m.sup.2 to 400 mg/m.sup.2.

8. A method according to claim 1, wherein said dosing regimen does not substantially increase the likelihood that said individual will develop palmar-plantar erythrodysesthesia during said dosing regimen.

9. A method according to claim 1, wherein said dosing regimen does not substantially increase the likelihood that said individual will develop congestive heart failure during said dosing regimen.

10. A method according to claim 1, wherein said dosing regimen does not substantially increase the likelihood that said individual will suffer cardiac death during said dosing regimen.

11. A method according to claim 1, wherein said dosing regimen comprises six consecutive 3-week long treatment cycles.

12. A method according to claim 11, wherein said nonpegylated liposomal doxorubicin is administered at a dose level of about 50 mg/m.sup.2 doxorubicin on day 1 of each treatment cycle, said paclitaxel[taxane] is administered at a dose level of about 80 mg/m.sup.2 on day 1 of the first treatment cycle and every week thereafter or at a dose level of about 75 mg/m.sup.2 on day 1 of each treatment cycle or at a dose level of from 200 mg/m.sup.2 to 250 mg/m.sup.2 on day 1 of each treatment cycle, and said trastuzumab is administered at a dose level of about 4 mg/kg on day 1 of the first treatment cycle and every week thereafter at a dose level of about 2 mg/kg.

13. A method according to claim 12, wherein said paclitaxel is administered at a dose level of about 80 mg/m.sup.2 on day 1 of the first treatment cycle and every week thereafter.

Details for Patent 8,026,267

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 09/25/1998 ⤷  Try a Trial 2029-04-08
Genentech, Inc. HERCEPTIN trastuzumab For Injection 103792 02/10/2017 ⤷  Try a Trial 2029-04-08
Genentech, Inc. HERCEPTIN HYLECTA trastuzumab and hyaluronidase-oysk Injection 761106 02/28/2019 ⤷  Try a Trial 2029-04-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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