FDA Advisory Committee Recommends Gloucester Pharmaceuticals` Romidepsin for Approval for Cutaneous T-cell Lymphoma
CAMBRIDGE, Mass.--(Business Wire)--
Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory
Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted
10 in favor with one abstention to recommend approval of romidepsin to treat
patients with cutaneous T-cell lymphoma (CTCL). CTCL is a type of non-Hodgkin's
lymphoma, which is a cancer of the immune system. A New Drug Application (NDA)
for romidepsin in CTCL is under review with the FDA and a Prescription Drug User
Fee Act (PDUFA) date of November 12, 2009 has been set.
"We are pleased that the advisory committee has voted so strongly to recommend
approval of romidepsin," said Alan Colowick, M.D., M.P.H, Chief Executive
Officer of Gloucester. "Over the past year, Gloucester has presented the final
pivotal data for romidepsin in cutaneous T-cell lymphoma and compiled and
submitted the NDA for this promising drug candidate while also advancing a
second pivotal program in peripheral T-cell lymphoma and recently completing a
significant Series D financing. Today`s ODAC decision adds to a highly
productive year and we now look forward to the FDA`s continued review of the
NDA. If approved, we believe romidepsin may offer substantial hope and fill a
significant treatment void for patients with cutaneous T-cell lymphoma."
In the Phase 2B, international, multicenter registration study of romidepsin in
patients with CTCL (n=96, intent-to-treat), patients refractory to prior therapy
who received romidepsin had an overall response rate of 34% (33/96) [95%
confidence interval (CI): 25, 45]. This exceeded the primary endpoint of the
study which required the lower bound of the 95% CI be above 15%. Complete and
partial responses were observed at all stages of disease. The median duration of
response was 14.9 months. Importantly, despite the exclusion of steroid and
antihistamine use, most (63%) patients with moderate to severe pruritus at
baseline experienced significant pruritus relief, a key indicator of clinical
benefit. The most common adverse effects in clinical trials of romidepsin
include fatigue, gastrointestinal disturbances and generally mild to moderate
hematologic toxicity.
CTCL is caused by a mutation of T cells, unlike most non-Hodgkin's lymphomas
which are generally of B-cell origin. The malignant T cells involve the skin,
causing plaques, patches, erythroderma and/or tumors and can involve other
organs, including the blood lymph nodes and viscera. Romidepsin has received
Orphan Drug Designation from the FDA for the treatment of non-Hodgkin`s T-cell
lymphomas, including CTCL.
About Romidepsin
Romidepsin`s cyclic peptide structure is novel among members of a new class of
cancer drugs known as histone deacetylase (HDAC) inhibitors. HDAC inhibition has
been shown to increase acetylation of histones and other proteins. The
downstream effects of HDAC inhibition include growth inhibition, apoptosis,
inhibition of angiogenesis and differentiation. Nonclinical studies suggest that
romidepsin is a pan-HDAC inhibitor and is a potent inhibitor of Class I, Class
II and Class IV HDACs.
About Gloucester Pharmaceuticals
Gloucester Pharmaceuticals acquires clinical-stage oncology drug candidates and
advances them through regulatory approval and commercialization. The Company`s
first candidate, romidepsin, a novel histone deacetylase (HDAC) inhibitor, is in
late-stage development for T-cell lymphomas and has shown activity across a
range of hematologic malignancies. A New Drug Application for romidepsin in
cutaneous T-cell lymphoma (CTCL) is under review with the Food and Drug
Administration (FDA) and a Prescription Drug User Fee Act (PDUFA) date of
November 12, 2009 has been set. The Company is currently enrolling patients in a
registration trial for peripheral T-cell lymphoma (PTCL) and is evaluating
romidepsin in multiple additional indications including multiple myeloma. For
more information, please visit www.gloucesterpharma.com