Non-linear dosing of mirdametinib
The present disclosure relates to methods for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by administering to a patient in need thereof mirdametinib or a pharmaceutically acceptable salt thereof, such as by a certain dosing scheme.
1. 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 1.5 to 1.74 m 2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 4 mg mirdametinib twice daily.
2. The method of claim 1 , wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis.
3. The method of claim 2 , wherein in step (i), mirdametinib is selected based on a response rate of at least 70%.
4. 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 no more than 0.69 m 2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 1 mg mirdametinib.
5. The method of claim 4 , wherein the patient is administered 1 mg mirdametinib twice daily.
6. The method of claim 4 , wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis.
7. The method of claim 6 , wherein in step (i), mirdametinib is selected based on a response rate of at least 70%.
8. 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 0.7 to 1.04 m 2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 2 mg mirdametinib.
9. The method of claim 8 , wherein the patient is administered 2 mg mirdametinib twice daily.
10. The method of claim 8 , wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis.
11. The method of claim 10 , wherein in step (i), mirdametinib is selected based on a response rate of at least 70%.
12. 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 m 2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 3 mg mirdametinib.
13. The method of claim 12 , wherein the patient is administered 3 mg mirdametinib twice daily.
14. The method of claim 12 , wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis.
15. The method of claim 14 , wherein in step (i), mirdametinib is selected based on a response rate of at least 70%.