Merrimack MACK
today announced that ONIVYDE(TM) (irinotecan liposome injection) has been
approved by the U.S. Food and Drug Administration (FDA) in combination with
fluorouracil (5-FU) and leucovorin for the treatment of patients with
metastatic adenocarcinoma of the pancreas after disease progression
following gemcitabine-based therapy. ONIVYDE is not indicated for use as a
single agent. With this approval, ONIVYDE in combination with 5-FU and
leucovorin becomes the first and only FDA-approved treatment option for
patients in this setting.
Experience the interactive Multimedia News Release here:
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"This is an important day for patients facing pancreatic cancer," said
Andrea Wang-Gillam, M.D., Ph.D., Associate Professor of Medicine, Clinical
Director of GI Oncology Program, Division of Oncology, at Washington
University School of Medicine, St. Louis, and a key investigator on the
ONIVYDE Phase 3 NAPOLI-1 study. "With a long history of failed clinical
studies in the post-gemcitabine setting, this approval is a significant
achievement in the oncology community. It brings a new therapy to the many
patients who are facing this aggressive disease and are in need of treatment
options."
"We are thrilled to be able to deliver this groundbreaking therapy to
patients battling metastatic pancreatic cancer," said Robert Mulroy,
President and CEO of Merrimack. "Pancreatic cancer is an aggressive and
devastating disease, with very few patients surviving beyond one year.
ONIVYDE provides a clinically significant treatment option to a patient
population where there is currently no standard of care. We are grateful to
the many patients, clinicians, researchers and partners that worked with us
to make ONIVYDE available. Today's approval by the FDA is a pivotal
milestone in our company's history, representing years of hard work and
commitment to our mission of engineering new treatment options for cancer
patients in need."
The FDA approval is based on the results of an international Phase 3
randomized, controlled study (NAPOLI-1). In this study, ONIVYDE in
combination with 5-FU and leucovorin achieved its primary endpoint of a
significant improvement in overall survival (p=0.014, unstratified HR=0.68,
95% CI: [0.50--0.93]) with a 45% improvement in median overall survival of
6.1 months for patients receiving the ONIVYDE combination regimen compared
to 4.2 months for patients who received 5-FU and leucovorin alone. The
ONIVYDE combination also demonstrated improvement in progression free
survival (3.1 months vs. 1.5 months, HR=0.55, 95% CI: [0.41-0.75]). The
monotherapy regimen in this study did not achieve its primary endpoint and,
therefore, ONIVYDE is not indicated as a single agent. The most common
adverse reactions (>20 %) of ONIVYDE were diarrhea, fatigue/asthenia,
vomiting, nausea, decreased appetite, stomatitis and pyrexia, and the most
common severe laboratory abnormalities (> 10% Grade 3 or 4) were lymphopenia
and neutropenia. For additional safety information, please see Important
Safety Information including Boxed Warning below.
"This is a pivotal achievement for the pancreatic cancer community because
it provides a new treatment option for some patients facing this difficult
disease," said Julie Fleshman, President and CEO of the Pancreatic Cancer
Action Network. "We applaud the dedication of those involved in this
advancement, knowing it will impact our goal to double pancreatic cancer
survival by 2020."
There are approximately 49,000 patients diagnosed with pancreatic cancer
each year in the United States(1) , the overwhelming majority of whom have
adenocarcinoma(2) . Most patients receive gemcitabine-based therapy during
either adjuvant/neoadjuvant treatment for locally advanced disease or during
first- or second-line therapy for metastatic disease, but are left with no
standard of care therapy upon progression(3) . ONIVYDE in combination with
5-FU and leucovorin is now approved for these patients whose disease has
progressed following gemcitabine-based therapy.
Merrimack expects ONIVYDE to be available in the United States next week and
is committed to supporting rapid physician and patient access to this
therapy. PROVYDE(TM) (ONIVYDE Access Center) offers a variety of
reimbursement support services for healthcare providers and financial
assistance services for patients. For more information, please call
1-844-ONIVYDE or visit www.ONIVYDE.com.
Baxalta Incorporated BXLT is responsible for the development and
commercialization of ONIVYDE outside of the United States and Taiwan under
the exclusive licensing agreement that Merrimack and Baxalta entered into in
September 2014. In May 2015, the European Medicines Agency (EMA) accepted
for review Baxalta's marketing authorization application (MAA) for ONIVYDE
based on the same clinical results.
"We are excited that ONIVYDE (nal-IRI) will now be available to people
living with metastatic pancreatic cancer in the U.S. after they progress
from gemcitabine-based therapy," said David Meek, Executive Vice President
and President of Oncology at Baxalta. "Looking ahead, Baxalta continues to
work toward marketing authorization in Europe with the goal of providing
nal-IRI to patients in more countries around the world in need of new
options."
PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize
ONIVYDE in Taiwan. PharmaEngine filed a New Drug Application (NDA) with the
Taiwan FDA in May 2015.
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