J&J Zarnestra Slated For Oncologic Drugs Advisory Committee Review May 5
This article was originally published in The Pink Sheet Daily
The oral farnesyl transferase inhibitor has a user fee date of June 29 for treatment of newly diagnosed acute myeloid leukemia in patients aged 65 years and older. The tipifarnib NDA is based on Phase II non-survival data; a Phase III trial is underway.
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The oral oncologic, known by the proposed trade name Zarnestra, could be approved by the end of the first half based on J&J's filing under the continuous marketing application pilot program and an expected six-month review. Submission is premised on Phase II response data.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.
Encysive may be forced to make "significant reductions" to infrastructure and workforce, firm says June 15.