Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

BERLEX LABS' FLUDARA APPROVED APRIL 18 for the treatment of patients with B-cell chronic lymphocytic leukemia. The injectable drug is indicated for patients who have not responded to other treatments or whose disease has progressed during treatment with at least one standard alkylating agent-containing regimen. The approval for Fludara (fludarabine) comes approximately 17 months after the NDA was filed on Nov. 22, 1989. Fludara, an orphan drug, has been available to patients with refractory chronic lymphocytic leukemia since November 1989 through a Group C/Treatment IND. FDA's Oncologic Drugs Advisory Committee unanimously recommended Fludara for approval at its Sept. 11, 1990 meeting ("The Pink Sheet" Sept. 17, p. 3). Chronic lymphocytic leukemia is diagnosed in about 9,600 U.S. patients each year. For some time Fludara has been rated by FDA as a "1A" drug, a new chemical entity representing an important therapeutic gain over existing therapies. In one of the studies presented at the advisory committee meeting, the South West Oncology Group's Phase I/II study, patients received 15-25 mg/m bolus infusions of fludarabine over 30 minutes for five days every four weeks. Among the 32 patients in the SWOG study, four (13%) had complete responses and six (19%) had partial responses. In another study, the M. D. Anderson Phase I/II trial, patients were given 22-40 mg/m bolus infusions over 30 minutes for five days every three to four weeks. Of the 101 patients enrolled in the study, six (13%) evaluable patients had complete responses, and 17 (35%) had a partial response to treatment with Fludara. The median duration of response was 65 weeks in the SWOG study and 91 weeks in the Anderson trial, with median survival ranging from 82 to 137 weeks. During the meeting, an investigator noted that refractory CLL patients usually have an expected response rate of 5% to 10% and a median survival of six to 12 months. The committee based its recommendation mostly on response rates rather than survival data, given the lack of appropriate historical controls. Berlex' German parent, Schering AG, acquired Fludara when it purchased the pharmaceutical R&D operations of Triton Biosciences from Shell Oil ("The Pink Sheet" Sept. 24, 1990, T&G-2). That deal was announced nine days after the drug received the advisory committee's approval recommendation. Fludara was licensed from the National Cancer Institute in 1984.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts