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Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Receives Not Approvable Letter From FDA for Tipifarnib Based on Phase II Data

Raritan, NJ (June 30, 2005) Johnson & Johnson Pharmaceutical Research & Development, L.L.C., announced it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) for the tipifarnib new drug application (NDA), which was based on data from a single Phase II study. Tipifarnib is an oral medication studied to treat acute myeloid leukemia (AML) in elderly patients who are not candidates for standard chemotherapy. The not approvable letter explains why the NDA cannot be approved based on currently submitted data.

The company remains committed to the development of tipifarnib. Recognizing the unmet medical need in this area, the company is reviewing the FDA's letter and will determine appropriate next steps.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., completed the submission of the tipifarnib NDA to the FDA under the Continuous Marketing Application Pilot-1 Program in December 2004, and the application was discussed at a May 5, 2005, Oncology Drugs Advisory Committee meeting. As a drug intended to treat a life-threatening disease for which there is an unmet medical need, tipifarnib was granted "Fast Track" status by the FDA in June 2004. Tipifarnib also was granted Orphan Drug status, a designation given to medications used to treat a rare disease or condition.

AML is a rare but often fatal cancer that will impact nearly 12,000 Americans in 2005.

About Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based producer of health care products. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., with its headquarters in Raritan, NJ, has eleven sites throughout Europe and the United States. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide. Combining innovation and experience, the company's major therapeutic areas of focus include hematology, oncology, infectious disease, neurology and psychiatry, pain and women's health.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99(b) of the Company's Annual Report on Form 10-K for the fiscal year ended January 2, 2005. Copies of this Form 10-K are available online at www.sec.gov or on request from the Company. The Company assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

US FDA Panel Rejects J&J Leukemia Drug

ROCKVILLE, Md., MAY 05, 2005 (Reuters) - A U.S. advisory panel Thursday rejected Johnson & Johnson's Zarnestra (tipifarnib) for treating elderly leukemia patients who have only months to live and are poor candidates for chemotherapy.

The Food and Drug Administration panel voted 7-4 against recommending approval for Zarnestra for treating older patients newly diagnosed with acute myeloid leukemia (AML) who are too frail for chemotherapy and unlikely to benefit from it. The FDA usually follows its panels' advice.

Opponents said it was unclear which AML patients would benefit from Zarnestra. Only 11 percent of 135 patients in a study experienced complete remission, FDA reviewers said.

"I don't really know which patients are going to respond," said Dr. Bruce Cheson, a panel member and head of hematology at Georgetown University Hospital's Lombardi Comprehensive Cancer Center in Washington.

Johnson & Johnson was "disappointed with the vote and will await final guidance from the FDA," company spokeswoman Kate Purcell said.

Ageing stem cells at the root of infections, leukemia

June 22, 2005 - Scientists have reported that the incidence of leukemia and infections in elderly people may be due to the ageing stem cells.

Stem cells are undifferentiated cells that have the potential to regenerate itself and develop into all types of specialized cells types that may form various types of cells of the tissue from which it was taken.

Researchers working in the Stanford University School of Medicine have found that bone marrow stem cells slow down with age in their ability to produce new blood cells. This causes the lack of immunity in the elderly mice that may lead to infections. Also such slow down can also mean high incidence of leukemia due to cancer of the blood cells. This happens as the older blood forming cells use a gene that causes cancer. These aged stem cells continue functioning as before, only slow down considerably. This turn on the gene that causes cancer in the blood cells.

Another result of the study was that the aged stem cells even when are introduced in the younger mice, continue to behave as before, inculcating in the younger mice the same manifestations that were present in the older mice.

Reference: Proceedings of the National Academy of Sciences, June 2005

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