INDIANAPOLIS, May 4, 2016 /PRNewswire/ -- Eli Lilly and Company
(NYSE: LLY) announced today that the U.S. Food and Drug
Administration (FDA) has granted Priority Review for the biologics
license application (BLA) for olaratumab, a PDGFRα antagonist, in
combination with doxorubicin, for the potential treatment of people
with advanced soft tissue sarcoma (STS) not amenable to curative
treatment with radiotherapy or surgery.
Lilly has received additional designations for olaratumab from
the FDA, including Breakthrough Therapy, Fast Track and Orphan
Drug, for this indication. According to the FDA, Breakthrough
Therapy designation is a process designed to expedite the
development of a potential medicine that is intended to treat a
serious condition, and preliminary clinical evidence indicates that
the drug may demonstrate substantial improvement over available
therapy on a clinically significant endpoint.
"We are encouraged that the FDA has granted Priority Review for
olaratumab as a potential treatment for advanced soft tissue
sarcoma," said Richard Gaynor, M.D.,
senior vice president, product development and medical affairs for
Lilly Oncology. "We are hopeful that, if approved, olaratumab will
provide a meaningful addition to the limited treatment options for
this rare and difficult-to-treat disease."
Providing Priority Review status for olaratumab reinforces that
olaratumab is a potential medicine that treats a serious condition
and can provide significant improvement in the treatment of people
with advanced STS. Submission was completed in the first quarter of
2016.
The BLA submission for olaratumab was based upon the results
from a pivotal Phase 2 trial, JGDG, an open-label, randomized study
that compared olaratumab in combination with doxorubicin
chemotherapy to doxorubicin alone in patients with advanced STS not
amenable to curative treatment with surgery or radiotherapy.
Results from JGDG were presented at the 2015 American Society of
Clinical Oncology annual meeting and the 2015 Connective Tissue
Oncology Society annual meeting.
Lilly also submitted olaratumab to the European Medicines Agency
(EMA) in the first quarter of 2016, and the application is
currently being reviewed under an
accelerated assessment schedule.
About Olaratumab
Olaratumab is a human IgG1
monoclonal antibody that is designed to disrupt the PDGF Receptor-α
(platelet-derived growth factor receptor α) pathway on tumor cells
and on cells in the tumor microenvironment. This means it may cause
anticancer activity by targeting tumor cells directly, as well as
cells that surround and support tumor growth.
A Phase 3 trial of olaratumab and doxorubicin in advanced STS is
currently recruiting adult patients (ClinicalTrials.gov Identifier:
NCT02451943).
About Sarcomas
Sarcomas are a diverse and relatively
rare type of cancer that usually develop in the connective tissue
of the body, which include fat, blood vessels, nerves, bones,
muscles, deep skin tissues and cartilage. Soft tissue sarcoma (STS)
is a complex disease with multiple subtypes, making it very
difficult to treat. According to the American Cancer Society, in
2015 an estimated 12,000 new cases of STS were diagnosed, and
nearly 5,000 deaths from STS occurred in the U.S. alone.
About Lilly Oncology
For more than 50 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 forward-looking statements (as that term is defined in the
Private Securities Litigation Reform Act of 1995) about the
potential of olaratumab as a potential treatment of advanced soft
tissue sarcoma and reflects Lilly's current beliefs. However, as
with any pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
Among other things, there can be no guarantee that future study
results and patient experience will be consistent with the study
findings to date. There can also be no guarantee that olaratumab
will receive regulatory approval or that, if approved, it will
prove to be commercially successful. For further discussion of
these and other risks and uncertainties that could cause actual
results to differ 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.
Refer to: Karen Glowacki; kglowacki@lilly.com;
317-370-1177 (media)
Philip L. Johnson;
philip_johnson_l@lilly.com; 317-655-6874 (investors)
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SOURCE Eli Lilly and Company