Allos Therapeutics Announces FDA Advisory Committee to Review Pralatrexate for the Treatment of Patients with Relapsed or Ref...
August 10 2009 - 9:25AM
Business Wire
Allos Therapeutics, Inc. (Nasdaq: ALTH) announced today that the
Company has received notification from the U.S. Food and Drug
Administration’s (FDA) that the Oncologic Drugs Advisory Committee
(ODAC) will hold a meeting on September 2, 2009, to review the
Company’s New Drug Application (NDA) for pralatrexate for the
treatment of patients with relapsed or refractory peripheral T-cell
lymphoma (PTCL).
The Company submitted the NDA in March 2009. In May 2009, the
FDA accepted the NDA for priority review and established a
Prescription Drug User Fee Act date of September 24, 2009 for a
decision regarding approval of the NDA.
About Pralatrexate
Pralatrexate is a selective antifolate designed to accumulate
preferentially in cancer cells. Based on preclinical studies, the
Company believes that pralatrexate selectively enters cells
expressing RFC-1, a protein that is over expressed on certain
cancer cells compared to normal cells. Once inside cancer cells,
pralatrexate is efficiently polyglutamylated, which leads to high
intracellular drug retention. Polyglutamylated pralatrexate
essentially becomes “trapped” inside cancer cells, making it less
susceptible to efflux-based drug resistance. Acting on the folate
pathway, pralatrexate interferes with DNA synthesis and triggers
cancer cell death.
About Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) comprises a biologically
diverse group of blood cancers that account for approximately 10%
to 15% of all newly diagnosed cases of non-Hodgkin's lymphoma (NHL)
in the U.S. The American Cancer Society estimates that
approximately 66,000 new cases of NHL were diagnosed in the U.S. in
2008. The Company estimates the current annual incidence of PTCL in
the U.S. to be approximately 5,600 patients. There are currently no
pharmaceutical agents approved for use in the treatment of either
first-line or relapsed or refractory PTCL. In addition to those
PTCL patients who do not respond to first-line treatment, a
significant number of first-line responders relapse or become
refractory after treatment. According to published clinical data,
patients with aggressive PTCL have an overall five-year survival
rate of approximately 25% to 40%, depending on sub-type.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical
company committed to the development and commercialization of
innovative anti-cancer therapeutics. The Company’s product
candidate, pralatrexate, is a selective antifolate designed to
accumulate preferentially in cancer cells. The Company recently
announced that the U.S. Food and Drug Administration (FDA) accepted
its New Drug Application (NDA) for pralatrexate for patients with
relapsed or refractory peripheral T-cell lymphoma for priority
review and established a Prescription Drug User Fee Act date of
September 24, 2009 for a decision regarding approval of the NDA. In
addition, pralatrexate is being evaluated in other tumor types,
including solid tumors and a range of lymphoma sub-types. Allos
retains exclusive worldwide rights to pralatrexate for all
indications. The Company is headquartered in Westminster, CO. For
more information about Allos, visit www.allos.com.
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Sep 2024 to Oct 2024
Allos Therapeutics, Inc. (MM) (NASDAQ:ALTH)
Historical Stock Chart
From Oct 2023 to Oct 2024