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Kepivance

Clinical Pharmacology
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Clinical Pharmacology

Kepivance

Pharmacodynamics

Epithelial cell proliferation was assessed by Ki67 immunohistochemical staining in healthy subjects. A 3-fold or greater increase in Ki67 staining was observed in buccal biopsies from 3 of 6 healthy subjects given Kepivance® at 40 mcg/kg/day IV for 3 days, when measured 24 hours after the third dose. Dose-dependent epithelial cell proliferation was observed in healthy subjects given single IV doses of 120 to 250 mcg/kg 48 hours post-dosing.

Special Populations

No gender-related differences were observed in the pharmacokinetics of Kepivance® at doses £ to 60 mcg/kg. The pharmacokinetic profile in pediatric and geriatric populations (see PRECAUTIONS: Pediatric Use and Geriatric Use), or in patients with hepatic or renal insufficiency, has not been assessed.

CLINICAL STUDIES

The safety and efficacy of Kepivance® were established in a randomized placebo-controlled clinical study of 212 patients (Study 1) and a randomized, schedule-ranging, placebo-controlled clinical study of 169 patients (Study 2).

In Study 1, patients received high-dose cytotoxic therapy consisting of fractionated total-body irradiation (TBI) (12 Gy total dose), high-dose etoposide (60 mg/kg), and high-dose cyclophosphamide (100 mg/kg) followed by peripheral blood progenitor cell (PBPC) support for the treatment of hematological malignancies (NHL, Hodgkin's disease, AML, ALL, CML, CLL, or multiple myeloma). Patients were randomized to receive either Kepivance® (n = 106) or placebo (n = 106). Kepivance® was administered as a daily IV injection of 60 mcg/kg for 3 consecutive days prior to initiation of cytotoxic therapy and for 3 consecutive days following infusion of PBPC.

The main efficacy endpoint of Study 1 was the number of days during which patients experienced severe oral mucositis (Grade 3/4 on the WHO [World Health Organization] scale)1. Other endpoints included the incidence, duration and severity of oral mucositis and the requirement for opioid analgesia. There was no evidence of a delay in time to hematopoietic recovery in patients who received Kepivance® as compared to patients who received placebo. The efficacy results are presented in Table 1 and Figure 1.

Table 1. Efficacy Outcomes in Study 1

Kepivance™ (60 mcg/kg/day) (n = 106)

Placebo (n = 106)

Median* (25th, 75th percentile) Days of WHO Grade 3/4 Oral Mucositis**

3 (0, 6)

9 (6, 13)

Incidence of WHO Grade 3/4 Oral Mucositis

63% (67/106)

98% (104/106)

Median (25th, 75th percentile) Days of WHO Grade 3/4 Oral Mucositis in Affected Patients

6 (3, 8)

(n = 67)

9 (6, 13)

(n = 104)

Brand Name: Kepivance
Generic Name: Palifermin

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