INDIANAPOLIS, July 9, 2015 /PRNewswire/ -- The U.S. Food
and Drug Administration's (FDA) Oncologic Drugs Advisory Committee
(ODAC) met today to discuss the data supporting Eli Lilly and
Company's (NYSE: LLY) necitumumab in combination with gemcitabine
and cisplatin for use in first-line treatment of patients with
advanced squamous non-small cell lung cancer (NSCLC).
Squamous NSCLC is a devastating and difficult-to-treat form of
lung cancer. The five-year survival rate for patients with
metastatic disease is less than five percent.[1] Necitumumab in
combination with gemcitabine and cisplatin is the first regimen to
show a significant improvement in overall survival over
chemotherapy alone, specifically in the first-line setting.
"We are encouraged by the Committee's constructive discussion on
the benefit-risk profile of necitumumab as few advances have been
made over the past two decades in the first-line treatment of
advanced squamous NSCLC, leaving a significant unmet medical need,"
said Richard Gaynor, M.D., senior
vice president, product development and medical affairs for Lilly
Oncology. "We believe necitumumab with gemcitabine and cisplatin
represents a meaningful advance in the search for a new first-line
treatment option and look forward to working closely with the FDA
as they continue their review."
The FDA is expected to make a decision on Lilly's biologics
license application for necitumumab later this year.
About Necitumumab
Necitumumab is a recombinant human
IgG1 monoclonal antibody that is designed to block the ligand
binding site of the human epidermal growth factor receptor 1
(EGFR). Activation of EGFR has been correlated with malignant
progression, induction of angiogenesis and inhibition of apoptosis
or cell death.
About Squamous Non-Small Cell Lung Cancer
(NSCLC)
NSCLC is the most common type of lung cancer, and
accounts for about 85 percent of all lung cancer cases.[2] Squamous
NSCLC, which represents about 30 percent of all people affected by
NSCLC,[3] is a devastating, difficult-to-treat form of the disease.
Patients face an imposing disease and symptom burden with very poor
prognosis; the five-year survival rate for patients with metastatic
disease is less than five percent.[4] Little progress has been made
over the last two decades, particularly in the first-line setting,
leaving a significant unmet medical need. In order to address the
unique and complex needs of individual patients with advanced
squamous NSCLC, more first-line treatment options are needed.
About Lilly Oncology
For more than fifty years, Lilly
has been dedicated to delivering life-changing medicines and
support to people living with cancer and those who care for them.
Lilly is determined to build on this heritage and continue making
life better for all those affected by cancer around the world. To
learn more about Lilly's commitment to people with cancer, please
visit www.LillyOncology.com.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels. P-LLY
Lilly Forward-Looking Statement
This press release
contains certain "forward-looking statements" (as that term is
defined in the United States Private Securities
Litigation Reform Act of 1995) regarding necitumumab and reflects
Lilly's current beliefs. However, as with any pharmaceutical
product, there are substantial risks and uncertainties in the
process of drug research, development, and commercialization. Among
other risks, there can be no guarantee that this investigational
product will receive regulatory approval, or, if approved, that it
will become a commercially successful product. For further
discussion of these and other risks and uncertainties that could
cause actual results to differ materially from Lilly's
expectations, please see the company's latest Forms 10-K and 10-Q
filed with the U.S. Securities and Exchange Commission. Except
as required by law, Lilly undertakes no duty to update
forward-looking statements.
[1] Howlader N, Noone AM, Krapcho M. SEER Cancer Statistics
Review, 1975-2012, National Cancer Institute, Bethesda, MD,
http://seer.cancer.gov/csr/1975_2012/. April 2015. Accessed
June 12, 2015.
[2] American Cancer Society, What is non-small cell lung cancer?
http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed
June 12, 2015.
[3] Erickson HS, Wistuba II. Pathology of lung cancer. In Lung
cancer: a multidisciplinary approach to diagnosis and management.
Kernstine KH, Reckamp KL, Thomas C (eds). New York, NY: DemosMedical, Inc; 2010.
[4] Howlader N, Noone AM, Krapcho M. SEER Cancer Statistics Review,
1975-2012, National Cancer Institute, Bethesda, MD,
http://seer.cancer.gov/csr/1975_2012/. April 2015. Accessed
June 12, 2015.
Refer to:
|
Carla Cox;
coxcl@lilly.com; (317) 473-4368 (Lilly Oncology)
|
|
Mariann Caprino;
m.caprino@togorun.com; (917) 242-1087 (TogoRun)
|
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SOURCE Eli Lilly and Company