Amgen will launch Kepivance (palifermin) for oral mucositis in late January following FDA approval Dec. 15.

Kepivance is indicated to "decrease the incidence and duration of severe oral mucositis" (mouth sores) in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant.

The Kepivance BLA, which Amgen filed in June, received a priority review under FDA's "fast track" procedures (¹ Also see "Amgen Palifermin BLA For Mucositis Builds On Supportive Care Franchise; Priority Review Expected" - Pink Sheet, 24 June, 2004.).

"The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies," ² Kepivance labeling states.

The potential market for the biologic is eventually expected to be much broader than that allowed by the current indication; Amgen plans to seek additional solid tumor supportive care indications for palifermin (³ Also see "Amgen Expects Palifermin BLA To Clear FDA Shortly" - Pink Sheet, 8 December, 2004.).

Kepivance is the first treatment approved by FDA for oral mucositis.

"The recommended dosage of Kepivance is 60 mcg/kg/day, administered as an IV bolus injection for three consecutive days before and three consecutive days after myelotoxic therapy for a total of six doses," labeling says.

Kepivance administration should not occur within 24 hours before, after or during infusion of myelotoxic chemotherapy administration, labeling notes.

"In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis," the label's Precautions section states.

Kepivance's label also includes the following precaution: "Kepivance has been shown to enhance the growth of human epithelial tumor cell lines in vitro and to increase the rate of tumor cell line growth in a human carcinoma xenograft model."

The Precautions section notes that Kepivance led to fertility impairment in rats, and was embryotoxic in rabbits and rats.

FDA approval of Kepivance was based on two placebo-controlled clinical studies, with 212 patients in Study 1 and 169 patients in Study 2.

"The main efficacy endpoint of Study 1 was the number of days during which patients experienced severe oral mucositis (Grade 3/4)," labeling says.

Additional endpoints for Study 1 included the incidence, duration and severity of oral mucositis, and the requirement for opioid analgesia.

The Kepivance arm experienced a median six days fewer of grade 3/4 oral mucositis. Incidence of grade 3/4 oral mucositis for the Kepivance arm was 63%, compared with 98% of patients on placebo.

Study 1 showed "no evidence of a delay in time to hematopoietic recovery in patients who received Kepivance as compared to patients who received placebo," labeling says.

Study 2 compared varying schedules of Kepivance to placebo. "The results of Study 1 were supported by results observed in the subset of patients in Study 2 who received the same dose and schedule of Kepivance as given in Study 1."

- Adam Eckstein

Amgen Will Launch Palifermin In Late January Under Brand Name Kepivance

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