Following slides presented by

1
Following slides presented by Lynn E. Spitler,
M.D. Northern California Melanoma Center during
the open public hearing of the Oncologic Drugs
Advisory Committee meeting February 27, 2002
2
Suggested Policy

• Patients who choose not to undergo therapy with
  high-dose interferon (HDI) after having been
  fully informed of the risk/benefit ratio should
  be permitted to choose treatment with
  investigational agents in approved clinical
  trials.
• Such patients should sign a Consent Form which
  clearly states that high-dose interferon is the
  treatment approved by the FDA for adjuvant
  therapy of high-risk melanoma.

3
Attachments Indicating Support of Suggested Policy

• Form supporting suggested policy signed by 37
  doctors specializing in the care of melanoma
  patients.
• Letters supporting suggested policy from 20
  patients and/or their families
• Other
• Letter from Dr. Richard L. Schilsky, Chair, CALGB
• Letter from Dr. Robert Dillman, Chair, Society of
  Biological Therapy
• Letter from Jeff Patterson, Co-founder of The
  Melanoma Patients Information Page
• Letter from Casey Culbertson, MD, Vice Chairman
  Melanoma Research Foundation
• Letter from Prof. Alexander M.M. Eggermont, MD,
  PhD, EORTC Melanoma Group