Amgen is understood to be expecting FDA approval of the oral mucositis therapy palifermin as early as this week.

Amgen filed a BLA for palifermin in June, and the product is receiving 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.).

Amgen's initial submission for palifermin (or recombinant human keratinocyte growth factor) seeks approval 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 bone marrow transplant.

The eventual market is expected to be much broader as Amgen supplements the filing with additional solid tumor supportive care indications.

- Michael McCaughan

Amgen Expects Palifermin BLA To Clear FDA Shortly

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