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Expert Interview

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Discussing Mirdametinib, an investigational MEK inhibitor, in neurofibromatosis type 1 (NF1), and how it compares to selumetinib

Ticker(s): SWTX

Who's the expert?

Institution: Mayo Clinic

  • Consultant, Department of Medical Genetics & Director of NF1 clinic at Mayo.
  • Research involves several collaborative basic research studies in the field of neurofibromatosis, in conjunction with Mayo's Neuro-Oncology Program and departments of Radiology and Neurologic Surgery.
  • Holds a leadership role in collaborative studies looking at children, adolescents and young adults with neurofibromatosis 1 and progressive plexiform neurofibromas as well as adult patients with neurofibromatosis 1 and extensive plexiform and paraspinal neurofibromas.

Interview Questions
Q1.

Roughly how many patients with neurofibromatosis do you manage?

Added By: c_admin
Q2.

On the Koselugo Label, the response rate is 66%, however under reins criteria it is 41%.  Mirdametinib under BICR is 51%.  What is the difference between Reins Criteria and BICR?  Does Koselugo have a better responder rate of 66% or should you use the reins criteria of 41?

Added By: mathew
Q3.

Why is Koselugo not approved for Adults?  Do Adults need treatment?  How do Plexiform present in Adults vs Pediatrics?  

Added By: mathew
Q4.

How significant is the food effect?  I understand that Mirda does not require Fasting but Koselugo does require fasting?  Is this a big differentiation feature?  Do both still require twice a day dosing?

Added By: mathew
Q5.

Do you surgically resect after using a MEK inhibitor?

Added By: mathew
Q6.

What is the drop out rate that you have observed in the real world with Koselugo?

Added By: mathew
Q7.

It appears that Mirda has a significantly higher grade 3 AE event vs Koselugo?  Yet discontinuation is less, why?

Added By: mathew
Q8.

Would a once a day or less frequent dose be a value add to the field?

Added By: mathew

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