Novel antitumoral use of cabazitaxel
AssigneeAventis Pharma S.A.
InventorSunil GUPTA
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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.
Claims33
A method for treating prostate cancer in a patient in need thereof comprising administering to said patient 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.
An article of manufacture comprising:
- 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.
An article of manufacture comprising:
- 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.
A package comprising cabazitaxel and a label, said label comprising one or more messages that:
- 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;
- or
- c) the median number of cycles was 6 in the cabazitaxel group and 4 in the mitoxantrone group.
A package comprising cabazitaxel and a label, said label comprising one or more messages that:
- a) neutropenic deaths have been reported;
- b) frequent blood counts should be obtained to monitor for neutropenia;
- or
- c) cabazitaxel should not be given if neutrophil counts are ≦1,500 cells/mm3.
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%).
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%).
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%).
A method of promoting the use of cabazitaxel, the method comprising the step of conveying to a recipient at least one message selected from:
- 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;
- or
- h) cabazitaxel is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or drugs formulated with polysorbate 80.
A method of providing cabazitaxel, wherein said cabazitaxel is provided along with information indicating that:
- 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;
- or
- h) cabazitaxel is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or drugs formulated with polysorbate 80.
Dependencies are inferred from the claim text.