Chemo-Naïve CRPC Indication definition

Chemo-Naïve CRPC Indication means the treatment of prostate cancer in a population consisting of patients satisfying all three ((a), (b) and (c)) of the following inclusion criteria: (a) prior treatment failure (i) on one or more luteinizing hormone-releasing hormone analog drugs or (ii) after surgical castration; (b) prior treatment failure on one or more androgen receptor antagonist drugs; and (c) no prior exposure to chemotherapy for prostate cancer.
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Related to Chemo-Naïve CRPC Indication

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation: