Mirdametinib treatment
AssigneeSpringworks Therapeutics, Inc.
InventorsUchenna H Iloeje, Abraham J Langseth, Todd Shearer
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Abstract
The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC0-tau less than 400 ng h/mL, (ii) a Cmax no more than 40 ng/mL, or (iii) both.
Claims30
A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) comprising orally administering an effective amount of mirdametinib to the patient, wherein
- (I) an amount of mirdametinib is administered on the first day of treatment to provide an AUC0-tau less than 300 ng·h/mL;
- and
- (II) (a) for a patient having a body surface area no more than 0.69 m2, the patient is initially administered 1 mg mirdametinib,
- (b) for a patient having a body surface area of 0.7 to 1.04 m2, the patient is initially administered 2 mg mirdametinib, or
- (c) for a patient having a body surface area of 1.05 to 1.49 m2, the patient is initially administered 3 mg mirdametinib.
A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) that is progressing or causing significant morbidity comprising orally administering an effective amount of mirdametinib to the patient, wherein
- (I) an amount of mirdametinib is administered on the first day of treatment to provide an AUC0-tau less than 400 ng·h/mL;
- and
- (II) (a) for a patient having a body surface area no more than 0.69 m2, the patient is initially administered 1 mg mirdametinib twice daily,
- (b) for a patient having a body surface area of 0.7 to 1.04 m2, the patient is initially administered 2 mg mirdametinib twice daily, and
- (c) for a patient having a body surface area of 1.05 to 1.49 m2, the patient is initially administered 3 mg mirdametinib twice daily.
A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) and a body surface area no more than 0.69 m2 comprising orally administering on the first day of treatment 1 mg of mirdametinib to the patient to achieve an AUC0-tau less than 300 ng·h/mL.
A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) and a body surface area of 1.05 to 1.49 m2 comprising orally administering on the first day of treatment 3 mg of mirdametinib to the patient to achieve an AUC0-tau less than 300 ng·h/mL.
Dependencies are inferred from the claim text.