Food and Drug Administration

Oncologic Drugs Advisory Committee

March 12, 2003


Accelerated Approvals in Oncology, Dr. Richard Pazdur, MD, FDA (HTM) (PPT)

Accelerated Approvals in Oncology 0 A 10-Year Experience, Dr. Dagher, FDA (HTM) (PPT)


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

DOXIL® (doxorubicin HCI liposome injection) - Treatment of AIDS-Related Kaposi's Sarcoma, Johnson & Johnson (HTM) (PPT)

DOXIL® (doxorubicin HCI liposome injection) - Treatment of Advanced, Metastatic Ovarian Cancer, Johnson & Johnson (HTM) (PPT)

ONTAK® (denileukin diftitox) Post-Approval Clinical Commitment, Ligand Pharmaceuticals (HTM) (PPT)

Ethyol® Non-Small Cell Lung Cancer Indication, MedImmune Oncology (HTM) (PPT)

Open Public Hearing

Accelerated Approval - Moving Forward for Cancer Patients, Dr. Walker (HTM) (PPT)

Presentation by Dr. Burroughs (HTM) (PPT)