January 2003

Jane S. Ricciuti, RPh, MS

January 16, 2003

Introduction

The US Food and Drug Administration (FDA) approved Humira (adalimumab), a novel recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). Humira is indicated for the treatment of patients with rheumatoid arthritis.

In December 2002, the FDA also approved 2 antineoplastic agents for first-line therapy. The first is Gleevec (imatinib mesylate) for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia. The second agent is Taxotere (docetaxel) in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer (NSCLC).

Labeling for Premarin (conjugated estrogens) and Prempro/Premphase (conjugated estrogens/medroxyprogesterone acetate) was also revised to include information on the recent results from the Women's Health Initiative and the increased risk of cardiovascular events and cancer.

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

Antidepressants

Lexapro (escitalopram oxalate) Oral Solution

Antidiabetic agents

Avandia (rosiglitazone maleate) Tablets
Starlix (nateglinide) Tablets

Antineoplastic agents

Gleevec (imatinib mesylate)
Taxotere (docetaxel) Injection

Antipsychotic agents

Clozaril (clozapine) Tablets

Antiviral agents

Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) Combination Therapy
Viread (tenofovir disoproxil fumarate) Tablets

Estrogens

Premarin (conjugated estrogens) Tablets
Prempro and Premphase (conjugated estrogens/medroxyprogesterone acetate) Tablets

Rheumatologic agents

Humira (adalimumab)

Vaccines

Pediarix (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B [recombinant] and inactivated poliovirus vaccine combined)

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Cite this: January 2003 - Medscape - Jan 16, 2003.

Table 1. Survival Analysis of Docetaxel in Combination Therapy for Chemotherapy-naive NSCLC
Comparison	Docetaxel + Cisplatin (n = 408)	Vinorelbine + Cisplatin (n = 405)
Kaplan-Meier estimate of median survival	10.9 months	10 months
P value	0.122
Estimated hazard ratio	0.88
Adjusted 95% CI	(0.74, 1.06)

Table 2. *Pegasys* and *Copegus* Dosing Recommendations
Genotype	Pegasys Dose	Copegus Dose	Duration
Genotype 1, 4	180 mcg	< 75 kg = 1000 mg	48 weeks
Genotype 1, 4	180 mcg	≥ 75 kg = 1200 mg	48 weeks
Genotype 2, 3	180 mcg	800 mg	24 weeks

Table 3. Sustained Virologic Response as a Function of Genotype (Study 5)
	24 Weeks Treatment		48 Weeks Treatment
	Pegasys + Copegus 800 mg (n = 207)	Pegasys + Copegus 1000 mg or 1200 mg (n = 280)	Pegasys + Copegus 800 mg (n = 361)	Pegasys + Copegus 1000 mg or 1200 mg (n = 436)
Genotype 1	29/101 (29%)	48/118 (41%)	99/250 (40%)	138/271 (51%)
Genotype 2-3	79/96 (82%)	116/144 (81%)	75/ 99 (76%)	117/153 (76%)

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January 2003

Introduction

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