NOVEL ANTITUMORAL USE OF CABAZITAXEL
First Claim
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1. A method for treating prostate cancer in a patient in need thereof comprising administering to said patient a compound of formula
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Accused Products
Abstract
The invention relates to a compound of formula:
which may be in base form or in the form of a hydrate or a solvate, in combination with prednisone or prednisolone, for its use as a medicament in the treatment of prostate cancer, particularly metastatic prostate cancer, especially for patients who are not catered for by a taxane-based treatment.
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Citations
33 Claims
- 1. A method for treating prostate cancer in a patient in need thereof comprising administering to said patient a compound of formula
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25. An article of manufacture comprising:
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a) a packaging material; b) cabazitaxel, and c) a label or package insert contained within the packaging material indicating that cabazitaxel should not be given to patients with neutrophil counts of ≦
1,500 cells/mm3.
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26. An article of manufacture comprising:
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a) a packaging material; b) cabazitaxel, and c) a label or package insert contained within the packaging material indicating that severe hypersensitivity reactions can occur.
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27. A package comprising cabazitaxel and a label, said label comprising one or more messages that:
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a) the efficacy and safety of cabazitaxel in combination with prednisone were evaluated in patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing regimen; b) a total of 755 patients were randomized to receive either cabazitaxel 25 mg/m3 every 3 weeks for a maximum of 10 cycles with prednisone mg orally daily, or to receive mitoxantrone 12 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone 10 mg orally daily;
orc) the median number of cycles was 6 in the cabazitaxel group and 4 in the mitoxantrone group.
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28. A package comprising cabazitaxel and a label, said label comprising one or more messages that:
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a) neutropenic deaths have been reported; b) frequent blood counts should be obtained to monitor for neutropenia;
orc) cabazitaxel should not be given if neutrophil counts are ≦
1,500 cells/mm3.
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29. A package comprising cabazitaxel and a label said label comprising a printed statement which informs a reader that the mean Cmax of cabazitaxel in patients with metastatic prostate cancer was 226 ng/mL (CV 107%).
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30. A package comprising cabazitaxel and a label, said label comprising a printed statement which informs a reader that the mean AUC of cabazitaxel in patients with metastatic prostate cancer was 991 ng·
- h/mL (CV 34%).
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31. A package comprising cabazitaxel and a label, said label comprising a printed statement which informs a reader that cabazitaxel has a plasma clearance of 48.5 L/h (CV 39%).
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32. A method of promoting the use of cabazitaxel, the method comprising the step of conveying to a recipient at least one message selected from:
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a) neutropenic deaths have been reported; b) frequent blood counts should be obtained to monitor for neutropenia; c) cabazitaxel should not be given if neutrophil counts are ≦
1,500 cells/mm3;d) severe hypersensitivity can occur; e) severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and brochospasm; f) discontinue cabazitaxel immediately if severe reactions occur; g) discontinue cabazitaxel immediately if severe reactions occur and administer appropriate therapy;
orh) cabazitaxel is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or drugs formulated with polysorbate 80.
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33. A method of providing cabazitaxel, wherein said cabazitaxel is provided along with information indicating that:
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a) neutropenic deaths have been reported; b) frequent blood counts should be obtained to monitor for neutropenia; c) cabazitaxel should not be given if neutrophil counts are 1,500 cells/mm3; d) severe hypersensitivity can occur; e) severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and brochospasm; f) discontinue cabazitaxel immediately if severe reactions occur; g) discontinue cabazitaxel immediately if severe reactions occur and administer appropriate therapy;
orh) cabazitaxel is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or drugs formulated with polysorbate 80.
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Specification
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Current AssigneeSanofi Mature IP (Sanofi )
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Original AssigneeAventis Pharma SA (Sanofi )
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InventorsGUPTA, Sunil
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Granted Patent
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Time in Patent OfficeDays
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Field of Search
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US Class Current424/85.1
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CPC Class CodesA61K 2300/00 Mixtures or combinations of...A61K 31/164 of a carboxylic acid with a...A61K 31/337 having four-membered rings,...A61K 31/56 Compounds containing cyclop...A61K 31/573 substituted in position 21,...A61K 38/193 Colony stimulating factors ...A61K 45/06 Mixtures of active ingredie...A61P 13/08 of the prostateA61P 15/00 Drugs for genital or sexual...A61P 25/16 Anti-Parkinson drugsA61P 35/00 Antineoplastic agentsA61P 35/04 specific for metastasisA61P 43/00 Drugs for specific purposes...
