The Key Players In Getting Proleukin Approved
Your article "Heartbreak and triumph in biotech land" (Top of the News, Feb. 3) creates a false impression about the process leading to the recent Food & Drug Administration Advisory Committee recommendation for approval of Proleukin (Interleukin-2) as a treatment for kidney cancer. In particular, the article incorrectly implies that Chiron Corp.'s "savvy" management somehow played a key role in the approval process.
In doing so, it slights the actual contributions of the highly professional and dedicated team of research and development scientists, pharmacologists, clinicians, managers, and supporting staff from Cetus Corp., as well as the distinguished group of clinical investigators at the National Cancer Institute and other national cancer centers. Chiron management had virtually no role in the process leading up to the FDA Advisory Committee's review on Jan. 17.
Chiron senior managment did not "resubmit" IL-2, nor did "the company orchestrate a more organized presentation" to the FDA panel. All of the data for Proleukin's review had been submitted to the FDA prior to the merger. Chiron simply encouraged the Cetus team to do its job.
The FDA presentation was given entirely by Cetus employees and their clinical investigators. A large dedicated support group within Cetus had been working for nearly a decade to make Proleukin available to kidney cancer patients, and it worked closely together and with the FDA over the past 18 months to generate additional data and analysis for a full review by the advisory committee.
Virtually all of this activity occurred prior to last month's Chiron-Cetus merger. During the meeting, a number of members of the advisory committee, including Dr. Jerome Groopman, complimented the quality, comprehensiveness, and clarity of the data and the presentations made by the FDA, Cetus Oncology, and the National Cancer Institute and other clinical investigators. Chiron's confidence in the ability of this Cetus team played a large role in Chiron's valuation of a merger between the two companies.
William J. Rutter
Edward E. Penhoet
Vice-Chairman and CEO