Speaking of meetings, ONTAK is on schedule:
CENTER FOR DRUG EVALUATION AND RESEARCH
FOOD AND DRUG ADMINISTRATION
ADVISORS AND CONSULTANTS STAFF
JUNE 1998 MEETING LIST
ONCOLOGIC DRUGS ADVISORY COMMITTEE
June 1, 1998, 8:30 a.m. to 5:30 p.m., and June 2, 8 a.m. to 5:30 p.m., Gaithersburg Hilton, Grand Ballroom, 620 Perry Parkway,
Gaithersburg, MD.
ADDITIONAL INFORMATION: Karen M. Templeton-Somers, Ph.D., Center for Drug Evaluation and Research (HFD-21),
301-443-4090 .Oral presentations from the public will be scheduled between approximately 8:45 a.m. and 9:15 a.m. on June 1,
1998, and 8:15 a.m. and 8:45 a.m. on June 2, 1998.
AGENDA: On June 1, 1998, the committee will discuss: 1) new drug application (NDA) 20-892 AD32 (valrubicin 40 mg/mL),
Anthra Pharmaceuticals, Inc., indicated for the treatment of refractory carcinoma in situ of the urinary bladder; and 2) NDA
supplement 20-449/S-005 Taxotere (docetaxel) for Injection Concentrate, Rhone-Polenc Rorer Pharmaceuticals,Inc., indicated for
the treatment of patients with locally advanced or metastatic breast cancer who have failed previous chemotherapy. On June 2,
1998, the committee will discuss: 1)biologics license application (BLA) 97-1325 ONTAKJ (denileukin diftitox) Injection (DAB389
IL-2), Seragen, Inc., indicated for the treatment of cutaneous T-cell lymphoma (CTLC); and 2) NDA supplement 20-671/S-004
Hycamtin (topotecan Hcl) for Injection, SmithKline Beecham Pharmaceuticals, indicated for the second-line treatment of patients
with small cell lung cancer. |
