Amgen is looking to build on its oncology supportive care business with the BLA submission for its oral mucositis agent, palifermin.

Priority review is expected for the palifermin BLA, which was submitted under FDA's fast track regulations. Amgen noted there are no approved therapies to treat the severity and duration of mucositis; current treatment is limited to pain therapies.

The requested indication is "to reduce the incidence, duration and severity of oral mucositis in patients with hematologic malignancies undergoing high-dose chemotherapy, with or without irradiation, followed by a bone marrow transplant," Amgen said June 24.

Amgen estimates the patient population for the bone marrow indication at approximately 11,000 patients. However, the firm plans to expand palifermin's use with supplemental filings in solid tumors, bringing the patient population to 400,000.

The BLA for the recombinant human keratinocyte growth factor is based on a single Phase III study. In the pivotal trial, patients receiving palifermin "suffered less oral mucositis (grades 2-4) compared to those receiving placebo (15.7 days vs. 8.4 days)," Amgen said.

Palifermin also reduced the incidence of severe mucositis, with 20% of patients experiencing grade 4 mucositis vs. 62% of placebo patients.

Amgen currently markets the supportive care products Aranesp , for chemotherapy-induced anemia, and Neupogen and Neulasta , for the prevention of febrile neutropenia in chemo patients.

The firm also appears poised to move into cancer treatment; in addition to its Phase III epidermal growth factor receptor inhibitor panitumumab, the recent acquisition of Tularik added two late-stage oncology therapeutics, T67 and T607 (¹ Also see "Amgen's $1.3 Bil. Acquisition Of Tularik Would Yield Two Late-Stage Oncologics" - Pink Sheet, 29 March, 2004.).

- Mary Jo Laffler

Amgen Palifermin BLA For Mucositis Builds On Supportive Care Franchise; Priority Review Expected

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