December 2004

Jane S. Ricciuti, RPh, MS

December 15, 2004

Introduction

The US Food and Drug Administration (FDA) approved Tysabri (natalizumab), a monoclonal antibody, for the treatment of patients with multiple sclerosis. Natalizumab is a recombinant humanized IgG4-kappa monoclonal antibody and has been approved for use in reducing the frequency of symptom flare-ups or exacerbations of the disease.

A new agent in the field of oncology has been approved, Tarceva (erlotinib), for the treatment of patients with non-small-cell lung cancer. Eloxatin (oxaliplatin) received a supplemental approval for use in combination with infusional 5-fluorouracil/leucovorin (5-FU/LV) for the adjuvant treatment of stage 3 colon cancer patients who have undergone complete resection of the primary tumor.

This month's column reviews FDA new product approvals and labeling changes for:

Antilipemic Agents

Omacor (omega-3 acid ethyl esters) Capsules
Tricor (fenofibrate) Tablets

Antineoplastic Agents

Eloxatin (oxaliplatin) Injection
Tarceva (erlotinib) Tablets

Central Nervous System Agents

Zomig(zolmitriptan) Tablets

Miscellaneous Agents

Mifeprex (mifepristone) Tablets
Tysabri (natalizumab) Injection

1 2 3 4 5

Next Section

Cite this: December 2004 - Medscape - Dec 16, 2004.

Table. Erlotinib Efficacy Results
	Erlotinib	Placebo	Hazard Ratio (I)	95% CI	P Value
Median survival, mos	6.7	4.7	0.73	0.61 0.86	< .0001
1-year survival, %	31.2	21.5
Median progression-free survival, wks	9.9	7.9	0.59	0.50 0.70	< .0001
Tumor response, %	8.9	0.9			< .0001
Median response duration, wks	34.3	15.9

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December 2004

Introduction

Tables

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