INDIANAPOLIS, Sept. 16, 2016 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) has issued a positive opinion recommending the granting of a
conditional marketing authorization for olaratumab, in combination
with doxorubicin, for the treatment of adults in the European Union
(EU) with advanced soft tissue sarcoma (STS) not amenable to
curative treatment with radiotherapy or surgery and who have not
been previously treated with doxorubicin. The CHMP reviewed
olaratumab under EMA's accelerated assessment program. If approved,
olaratumab will be marketed under the trade name LARTRUVO™.
This is the first regulatory step in the world towards approval
for olaratumab. The CHMP positive opinion is now referred for final
action to the European Commission, which grants marketing
authorization in the EU. The Commission usually makes a decision on
marketing authorization within two to three months of the CHMP
issuing its recommendation.
"Patients with advanced soft tissue sarcoma have been seeking
new treatment options that can potentially extend lives, so they
can have more time with their families and loved ones," said
Richard Gaynor, M.D., senior vice
president of product development and medical affairs for Lilly
Oncology. "Advanced soft tissue sarcoma is a rare disease that is
difficult to treat, and this milestone brings us one step closer to
providing physicians in Europe
with a new option that they can offer to their patients."
This will be Lilly's first conditional approval in the EU. As
part of a conditional marketing authorization, Lilly will need to
provide results from an ongoing Phase 3 study. This study,
ANNOUNCE, is fully enrolled. Until availability of the full data,
the CHMP will review the benefits and risks of olaratumab annually
to determine whether the conditional marketing authorization can be
maintained.
The EMA previously granted olaratumab with Orphan Drug
Designation for the treatment of soft tissue sarcoma in the EU.
The EU submission is based on data from Phase 2 JGDG, an
open-label, randomized trial 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 and who have not been previously treated
with doxorubicin. Efficacy endpoints included progression-free
survival, overall survival and objective response rate.
Lilly has also submitted the results of this study to the U.S.
Food and Drug Administration (FDA) for regulatory review. The FDA
recently granted Lilly Priority Review status for olaratumab. Lilly
also has received additional designations for olaratumab from the
FDA for this indication, including Breakthrough Therapy, Fast Track
and Orphan Drug.
Notes to Editor
About Olaratumab
Olaratumab
is a PDGFRα blocking antibody that specifically binds PDGFRα and
prevents receptor activation. Olaratumab exhibited in vitro
and in vivo anti-tumor activity against selected sarcoma
cell lines and disrupted the PDGFRα signaling pathway in in
vivo tumor implant models. Information about additional
clinical trials for olaratumab in sarcoma can be found at
ClinicalTrials.gov (in the search box on the home page, type in
"olaratumab").
A Phase 3 trial of olaratumab and doxorubicin in advanced STS is
fully enrolled (ClinicalTrials.gov Identifier: NCT02451943).
About the JGDG Trial
The open-label, randomized Phase
1b/2 study, JGDG, compared olaratumab in combination with
doxorubicin chemotherapy to the control arm of doxorubicin alone in
patients with unresectable, advanced STS not amenable to curative
treatment with surgery or radiotherapy. After confirmation of
safety in the Phase 1b portion of the study, 133 doxorubicin-naïve
patients were randomized 1:1 in the Phase 2 portion of the study. A
total of 66 patients were treated on the olaratumab-doxorubicin
arm, and 67 on the placebo-doxorubicin arm. Efficacy endpoints
included progression-free survival, overall survival and objective
response rate.
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. STS is a complex disease
with multiple subtypes, making it very hard to diagnose and
difficult to treat. For decades, there have been no front-line
therapeutic advancements for advanced STS that have improved
overall survival. An estimated 23,000 people in the EU will be
diagnosed with STS this year.
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.
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 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.
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 for any future indications or that 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)
|
Logo - http://photos.prnewswire.com/prnh/20031219/LLYLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/chmp-recommends-approval-of-lillys-olaratumab-in-combination-with-doxorubicin-for-advanced-soft-tissue-sarcoma-300329369.html
SOURCE Eli Lilly and Company