Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of FOLOTYN (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
-- Company to Host Webcast Conference Call on Wednesday, September 2 at 6:00 p.m. ET --
SILVER SPRING, Md.--(BUSINESS WIRE)--Allos Therapeutics, Inc. (Nasdaq: ALTH - News) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). PTCL comprises a biologically diverse group of aggressive blood cancers that has a worse prognosis than most other types of lymphoma, including B-cell lymphoma. If approved, FOLOTYN would be the first drug approved by the FDA for the treatment of relapsed or refractory PTCL.
The ODAC recommendation was based on results from PROPEL, a pivotal Phase 2 international trial that evaluated FOLTYN for the treatment of patients with relapsed or refractory PTCL. The PROPEL trial was conducted under an agreement reached with the FDA under its special protocol assessment, or SPA, process. The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of an NDA, and provides an agreement that the trial design, including trial size, clinical endpoints and data analyses are acceptable to the FDA.
The FDA is expected to make a decision whether to approve the Company’s New Drug Application (NDA) for FOLOTYN by September 24, 2009. While the FDA generally follows the recommendations of its advisory committees, it is not required to do so.
“We are very pleased that the advisory committee today voted to recommend accelerated approval of the FOLOTYN NDA,” said Paul L. Berns, chief executive officer at Allos Therapeutics, Inc. “We believe FOLOTYN has the potential to offer an important new treatment option for patients with relapsed or refractory PTCL, an indication for which there are currently no FDA-approved therapies and no accepted standard of care. We will continue to work with FDA to bring FOLOTYN to the U.S. market as soon as possible so that patients can benefit from this potential new treatment option.”
Conference Call Information
Allos will host a webcast conference call to review the outcome from the ODAC meeting on Wednesday, September 2, 2009 at 6:00 p.m. ET. Participants can access the call at 877-941-6009 (U.S. and Canada) or +480-629-9771 (international). To access the live audio webcast or the subsequent archived recording, visit the “Investors - Presentations and Events” section of the Company’s website at www.allos.com. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call. Callers can access the replay by dialing 800-406-7325 (domestic) or 303-590-3030 (international). The passcode is 4151544#. The webcast will be recorded and available for replay on the Company's website until September 11, 2009.
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The thought that this drug could help a patient get to a transplant was key to the yes vote. Close call. |
