INDIANAPOLIS, July 10, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced that the U.S. Food and Drug
Administration (FDA) has accepted and filed its New Drug
Application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4
& 6 inhibitor, and given the NDA a Priority Review designation.
The NDA includes the company's submission of abemaciclib for two
indications: abemaciclib monotherapy for patients with
hormone-receptor-positive (HR+), human epidermal growth factor
receptor 2-negative (HER2-) advanced breast cancer who had prior
endocrine therapy and chemotherapy for metastatic disease; and for
abemaciclib in combination with fulvestrant in women with HR+,
HER2- advanced breast cancer who had disease progression following
endocrine therapy. This submission is based on the MONARCH 1 and
MONARCH 2 studies, respectively.
"We are pleased that the FDA has granted abemaciclib Priority
Review, both as a potential monotherapy and combination therapy
[with fulvestrant] for patients with advanced breast cancer," said
Levi Garraway, M.D., Ph.D., senior
vice president, global development and medical affairs, Lilly
Oncology. "Breast cancer is a complex disease, and the need still
exists for new treatment options as patients face a significant
disease burden. We look forward to working with the FDA and
bringing this important potential treatment option to patients as
soon as possible."
In 2015, the FDA granted abemaciclib Breakthrough Therapy
Designation based on data from the breast cancer cohort expansion
of the company's Phase 1 trial, JPBA, which studied the efficacy
and safety of abemaciclib in women with advanced or metastatic
breast cancer. A drug that receives Breakthrough Therapy
Designation may be eligible for Priority Review, which aims to
expedite the review of applications for drugs that, if approved,
would represent a significant advance in treatment. With Priority
Review of a new drug, the FDA's goal is to take action within eight
months of receiving an application, compared with the standard
review timeframe of 12 months.1 Lilly is working closely
with the FDA and anticipates agency action on this application in
the first quarter of 2018.
In addition, Lilly intends to submit abemaciclib to European
regulators in the third quarter of 2017 and to Japanese regulators
before the end of 2017.
Notes to Editor
About Advanced Breast Cancer
Breast cancer is the
most common cancer in women worldwide with nearly 1.7 million new
cases diagnosed in 2012.2 Advanced breast cancer
includes metastatic breast cancer, cancer that has spread from the
breast tissue to other parts of the body, and locally or regionally
advanced breast cancer, meaning the cancer has grown outside the
organ where it started but has not yet spread to other parts of the
body.3 Of all early stage breast cancer cases diagnosed
in the U.S., approximately 30 percent will become metastatic and an
estimated six to ten percent of all new breast cancer cases are
initially diagnosed as being metastatic.4 Survival is
lower among women with a more advanced stage at diagnosis: 5-year
relative survival is 99 percent for localized disease, 85 percent
for regional disease, and 26 percent for metastatic disease. Other
factors, such as tumor size, also impacts 5-year survival
estimates.5
About Abemaciclib
In many cancers, uncontrolled cell
growth arises from a loss of cell cycle regulation due to increased
signaling from CDK4 and CDK6. Abemaciclib (LY2835219) is an
investigational, oral cell cycle inhibitor, designed to block the
growth of cancer cells by specifically inhibiting cyclin-dependent
kinases, CDK4 and CDK6, and was most active against Cyclin D1 and
CDK4 in cell-free enzymatic assays. In breast cancer, Cyclin
D1/CDK4 has been shown to promote phosphorylation of the
retinoblastoma protein (Rb), cell proliferation and tumor growth.
In hormone receptor-positive breast cancer cell lines, sustained
target inhibition by abemaciclib reduced phosphorylation of Rb,
inducing cell cycle arrest.
In addition to its current MONARCH clinical trials evaluating
abemaciclib in breast cancer, a Phase 3 trial of abemaciclib in
lung cancer is also underway.
For more information on additional abemaciclib trials, a
complete listing can be found on ClinicalTrials.gov (in the search
box on the home page, type in "abemaciclib").
About the MONARCH Clinical Trial Program
Lilly is
evaluating abemaciclib in the comprehensive MONARCH clinical
program, which includes the following studies:
MONARCH 1: a global Phase 2
study evaluating the efficacy and safety of abemaciclib monotherapy
in patients with HR+, HER2- advanced breast cancer who had prior
endocrine therapy and chemotherapy for metastatic disease.
MONARCH 2: a global Phase 3
study evaluating the efficacy and safety of abemaciclib, in
combination with fulvestrant, in patients with HR+, HER2- advanced
breast cancer who progressed on endocrine therapy.
MONARCH 3: a global Phase 3
study evaluating the efficacy and safety of abemaciclib, in
combination with an aromatase inhibitor, as initial endocrine-based
therapy for postmenopausal women with HR+, HER2- advanced breast
cancer who have had no prior systemic treatment for advanced
disease.
monarcHER: a global Phase 2
study evaluating abemaciclib plus trastuzumab (with or without
fulvestrant) in women with HR+, HER2+ advanced breast cancer.
MONARCH plus: a Phase 3
study evaluating the efficacy and safety of abemaciclib, in
combination with endocrine therapies, to support registration in
China.
neoMONARCH: a Phase 2 study
evaluating abemaciclib in the neoadjuvant setting, alone or in
combination with the non-steroidal aromatase-inhibitor anastrozole,
in postmenopausal women with previously untreated early stage HR+,
HER2- breast cancer.
monarchE: a global Phase 3
study evaluating the efficacy and safety of abemaciclib in the
adjuvant setting in patients with high-risk, early breast
cancer.
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
www.lilly.com/newsroom/social-channels. P-LLY
Fulvestrant (Faslodex®),
MedImmune/AstraZeneca. MedImmune Limited/AstraZeneca provided
fulvestrant for this trial.
© Lilly USA, LLC 2017. ALL
RIGHTS RESERVED.
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 abemaciclib as a potential treatment for
patients with breast cancer 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 abemaciclib will receive regulatory approvals or be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's most recent Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
1 U.S. Food and Drug Administration. CDER 21st
Century Review Process Desk Reference Guide.
https://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM218757.pdf.
Accessed: July 7, 2017.
2 World Cancer Research Fund International. Breast
Cancer.
http://www.wcrf.org/cancer_statistics/data_specific_cancers/breast_cancer_statistics.php.
Accessed: July 7, 2017.
3 American Cancer Society. Understanding Advanced
Cancer, Metastatic Cancer and Bone Metastases.
https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/what-is.html.
Accessed: July 7, 2017.
4 Metastatic Breast Cancer Network. 13 Facts about
Metastatic Breast Cancer.
http://www.mbcn.org/13-facts-about-metastatic-breast-cancer/.
Accessed: July 7, 2017.
5 American Cancer Society. Breast Cancer Facts &
Figures 2015-2016.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2015-2016.pdf.
Accessed: July 7, 2017.
Refer to:
Erin Graves;
graves_erin_elissa@lilly.com; 908-202-6354 (media)
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (investors)
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