Johnson & Johnson could see approval of its oral leukemia agent Zarnestra (tipifarnib) by mid-year.

The company announced Jan. 24 that submission of the oncologic was completed under FDA's Continuous Marketing Application Pilot 1 program.

CMA Pilot 1 allows sponsors of fast-track agents to submit NDAs in reviewable units.

"The standard FDA review time for the CMA Pilot 1 program is six months," J&J noted.

The last reviewable unit for the Zarnestra application was submitted on Dec. 29, setting up a user fee deadline of June 29.

The firm is seeking an indication for treatment of patients 65 years of age and older with newly diagnosed acute myeloid leukemia.

The submission is "based on Phase II clinical data, which use measurements of activity or responsiveness of a disease to the treatment rather than survival endpoints," the firm said.

A Phase III study intended to "fully demonstrate the clinical benefit of tipifarnib" in AML was initiated in October 2004, the company said.

Tipifarnib is understood to be in Phase III studies for use in combination with gemcitabine for treatment of RAS-dependent tumors and in Phase II for metastatic breast cancer and non-small cell lung cancer. Trials in pancreatic and colorectal cancer failed to show efficacy.

The agent is one of two that J&J is looking at to expand its oncology portfolio in 2005, the other being the sarcoma treatment Yondelis (trabectedin). A Yondelis NDA for soft tissue sarcoma is expected in the first half of 2005.

- Lee Szilagyi

J&amp;J Completes Tipifarnib Submission For Leukemia Under Pilot 1 Program

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J&J Completes Tipifarnib Submission For Leukemia Under Pilot 1 Program