INDIANAPOLIS, Nov. 24, 2015
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced
today that the U.S. Food and Drug Administration (FDA) has approved
Portrazza™ (necitumumab injection for intravenous use, 800 mg/50
mL), in combination with gemcitabine and cisplatin, as the first
biologic for the first-line treatment of people with metastatic
squamous non-small cell lung cancer (NSCLC). Portrazza is not
indicated for treatment of nonsquamous NSCLC.
Metastatic squamous NSCLC is a difficult-to-treat form of lung
cancer with few treatment options.[1],[2],[3],[4] The
five-year survival rate for patients with metastatic disease is
less than five percent.[5]
"We have seen advances in lung cancer in the last 20 years, but
not for the initial treatment of patients battling metastatic
squamous non-small cell lung cancer. This is a complex
disease and there is an urgent need for effective, first-line
treatments," said Richard Gaynor,
M.D., senior vice president, product development and medical
affairs for Lilly Oncology. "The approval of Portrazza is an
important step forward that reaffirms Lilly's commitment to
discovering new treatments that respond to the needs of individual
patients."
Portrazza has been granted Orphan Drug Designation by the FDA.
Orphan drug status is given in the U.S. by the FDA's Office of
Orphan Products Development (OOPD) to medicines that demonstrate
promise for the diagnosis and/or treatment of rare diseases or
conditions.
The Portrazza approval is based on the results of SQUIRE, an
open-label, randomized, multi-center Phase III trial that compared
first-line treatment with Portrazza in combination with gemcitabine
and cisplatin to treatment with gemcitabine and cisplatin alone in
patients with metastatic squamous NSCLC. The main outcome measure,
or primary endpoint, was overall survival. Portrazza is not
indicated for treatment of nonsquamous NSCLC. The labeling for
Portrazza contains Boxed Warnings regarding cardiopulmonary arrest
and hypomagnesemia. See the full Important Safety Information,
including Boxed Warnings, at the end of this press release and the
Prescribing Information.
"Lung cancer is an extremely complicated disease that requires a
variety of therapy options so doctors can choose an
appropriate treatment for each patient's unique
circumstances," said Bonnie J.
Addario, founder and chair of the Bonnie J. Addario Lung
Cancer Foundation, and a lung cancer survivor. "Today's approval
represents progress for patients diagnosed with metastatic squamous
non-small cell lung cancer, as each new therapy advances cancer
care and gives patients hope for improved outcomes."
Lilly is committed to offering assistance programs for eligible
patients receiving Portrazza, including a co-pay program that
allows qualified patients to pay no more than $25 per dose. Patients, physicians, pharmacists
or other healthcare professionals with questions about Portrazza
should contact The Lilly Answers Center at 1-800-LillyRx
(1-800-545-5979) or visit www.lilly.com.
About Portrazza (necitumumab)
Portrazza (necitumumab), in combination with gemcitabine and
cisplatin, is approved for the first-line treatment of people with
metastatic squamous non-small cell lung cancer (NSCLC). Portrazza
is not indicated for treatment of nonsquamous NSCLC. Portrazza 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. As demonstrated in preclinical studies,
EGFR plays a role in the formation (tumorigenesis) and spread
(metastasis) of tumors.[6]
About the SQUIRE Trial
SQUIRE was an open-label, randomized, multi-center Phase III
trial that compared first-line treatment with Portrazza in
combination with gemcitabine and cisplatin to treatment with
gemcitabine and cisplatin alone in patients with metastatic
squamous NSCLC. Patients on both arms of the study were allowed to
receive a maximum of six cycles of chemotherapy. Patients on the
Portrazza arm demonstrating at least stable disease continued to
receive additional cycles of Portrazza until disease progression or
unacceptable toxicity. The trial enrolled 1,093 people with stage
IV squamous NSCLC, of which 91 percent had a baseline performance
status (PS) 0-1, and nine percent had PS 2. Of patients enrolled,
91 percent had metastatic disease at two or more sites. The SQUIRE
study was conducted across 184 investigative sites in 26
countries.[7]
SQUIRE was the first and only randomized Phase III study
conducted specifically in patients with metastatic squamous NSCLC
to demonstrate a statistically significant improvement in overall
survival over gemcitabine and cisplatin alone, specifically in the
first-line setting. Portrazza combination therapy showed a
statistically significant improvement in overall survival, the
main outcome measure (HR 0.84; 95% CI: 0.74-0.96; p=0.01), with a
median overall survival of 11.5 months (95% CI: 10.4-12.6) for the
Portrazza arm, as compared to 9.9 months (95% CI: 8.9-11.1) for
those treated with gemcitabine and cisplatin alone. This translated
to a 16 percent reduction in risk of death. The percentage of
deaths at the time of analysis was 77 percent (418 patients) on the
Portrazza arm and 81 percent (442 patients) on the control arm. The
significant survival improvement observed in SQUIRE was supported
by a statistically significant improvement in progression-free
survival (HR 0.85; 95% CI: 0.74-0.98; p=0.02), with a median
progression-free survival (PFS) of 5.7 months (95% CI: 5.6-6.0) on
the Portrazza arm, as compared to 5.5 months (95% CI: 4.8-5.6) for
those treated with gemcitabine and cisplatin alone. The
percentage of events at the time of analysis was 79 percent (431
patients) on the Portrazza arm and 76 percent (417 patients) on the
control arm. Overall response rate (ORR) was also assessed and
there was no difference between arms, with an ORR of 31 percent
(95% CI: 27-35) for the Portrazza plus gemcitabine and cisplatin
arm and an ORR of 29 percent (95% CI: 25-33) for the gemcitabine
and cisplatin arm (p=0.40).
Cardiopulmonary arrest or sudden death occurred in 15 (3%) of
538 patients treated with Portrazza plus gemcitabine and cisplatin
as compared to three (0.6%) of 541 patients treated with
gemcitabine and cisplatin alone in SQUIRE. Twelve of the 15
patients died within 30 days of the last dose of Portrazza and had
comorbid conditions including history of coronary artery disease
(n=3), hypomagnesemia (n=4), chronic obstructive pulmonary disease
(n=7), and hypertension (n=5). Eleven of the 12 patients had an
unwitnessed death. Patients with significant coronary artery
disease, myocardial infarction within six months, uncontrolled
hypertension, and uncontrolled congestive heart failure were not
enrolled in SQUIRE. The incremental risk of cardiopulmonary arrest
or sudden death in patients with a history of coronary artery
disease, congestive heart failure, or arrhythmias as compared to
those without these comorbid conditions is not known.
Hypomagnesemia occurred in 83 percent of patients receiving
Portrazza in combination with gemcitabine and cisplatin, as
compared to 70 percent of patients treated with gemcitabine and
cisplatin alone. Hypomagnesemia was severe (grade 3 or 4) in 20
percent of patients on the Portrazza plus gemcitabine and cisplatin
arm, compared to seven percent of patients on the gemcitabine and
cisplatin alone arm. Because of these risks, the Portrazza
Prescribing Information contains instructions about monitoring for
electrolyte imbalances and treating as necessary. Portrazza
labeling contains additional Warnings and Precautions for venous
and arterial thromboembolic events (some fatal), dermatologic
toxicities, infusion-related reactions, increased toxicity and
increased mortality in patients with nonsquamous NSCLC, and
embryofetal toxicity. See the full Important Safety Information,
including Boxed Warnings, at the end of this press release and the
Prescribing Information.
The most common adverse reactions (all grades) observed in
Portrazza-treated patients at a rate of >15 percent and
>2 percent higher than gemcitabine and cisplatin alone were rash
(44% vs 6%), vomiting (29% vs 25%), diarrhea (16% vs 11%), and
dermatitis acneiform (15% vs 0.6%). The most common severe (grade 3
or higher) adverse events that occurred at a >2
percent higher rate in Portrazza-treated patients compared to
patients treated with gemcitabine and cisplatin alone were venous
thromboembolic events (5%; including pulmonary embolism), rash
(4%), and vomiting (3%). See the full Important Safety Information,
including Boxed Warnings, at the end of this press release and the
Prescribing Information.
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.[8] Squamous
NSCLC, which represents about 30 percent of all lung cancer cases,
is a devastating, difficult-to-treat form of the
disease.[1],[2],[3],[8] 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.[5] Until now, little progress has been
made over the last two decades, particularly in the first-line
setting, leaving a significant unmet medical
need.[4]
Lilly PatientOne
The Lilly PatientOne program addresses financial and coverage
issues for qualified uninsured, underinsured, and insured patients
who are prescribed a Lilly Oncology product. Lilly PatientOne
provides reimbursement assistance for eligible patients who are
prescribed a Lilly Oncology product, such as information about
coding and billing, prior authorization, benefits investigation,
and denied claim appeals, as well as operating a patient assistance
program. Lilly also offers a co-pay program that allows qualified
Portrazza patients to pay no more than $25 per dose. To learn more, visit
www.LillyPatientOne.com or call 1-866-4PatOne (1-866-472-8663).
INDICATION
Portrazza™ is indicated, in combination with gemcitabine and
cisplatin, for first-line treatment of patients with metastatic
squamous non-small cell lung cancer. Portrazza is not indicated for
treatment of nonsquamous non-small cell lung cancer.
IMPORTANT SAFETY INFORMATION FOR PORTRAZZA
WARNING:
CARDIOPULMONARY ARREST and HYPOMAGNESEMIA
- Cardiopulmonary
arrest and/or sudden death occurred in 3% of patients treated with
Portrazza in combination with gemcitabine and cisplatin. Closely
monitor serum electrolytes, including serum magnesium, potassium,
and calcium, with aggressive replacement when warranted during and
after Portrazza administration.
- Hypomagnesemia
occurred in 83% of patients receiving Portrazza in combination with
gemcitabine and cisplatin, and was severe in 20% of patients.
Monitor patients for hypomagnesemia, hypocalcemia, and hypokalemia
prior to each dose of Portrazza during treatment and for at least 8
weeks following completion of Portrazza. Withhold Portrazza for
grade 3 or 4 electrolyte abnormalities. Replete electrolytes as
medically appropriate.
|
Warnings and Precautions
Cardiopulmonary Arrest
- Cardiopulmonary arrest or sudden death occurred in 15 (3%) of
538 patients treated with Portrazza plus gemcitabine and cisplatin
as compared to 3 (0.6%) of 541 patients treated with gemcitabine
and cisplatin alone in study 1. Twelve of the 15 patients died
within 30 days of the last dose of Portrazza and had comorbid
conditions including history of coronary artery disease (n=3),
hypomagnesemia (n=4), chronic obstructive pulmonary disease (n=7),
and hypertension (n=5). Eleven of the 12 patients had an
unwitnessed death. Patients with significant coronary artery
disease, myocardial infarction within 6 months, uncontrolled
hypertension, and uncontrolled congestive heart failure were not
enrolled in study 1. The incremental risk of cardiopulmonary arrest
or sudden death in patients with a history of coronary artery
disease, congestive heart failure, or arrhythmias as compared to
those without these comorbid conditions is not known. Closely
monitor serum electrolytes, including serum magnesium, potassium,
and calcium prior to each infusion of Portrazza during treatment
and after Portrazza administration for at least 8 weeks after the
last dose. Withhold Portrazza for grade 3 or 4 electrolyte
abnormalities; subsequent cycles of Portrazza may be administered
in these patients once electrolyte abnormalities have improved to
grade <2. Replete electrolytes as medically appropriate.
Hypomagnesemia
- Hypomagnesemia occurred in 83% of 461/538 patients with
available laboratory results treated with Portrazza as compared to
70% of 457/541 patients with available laboratory results treated
with gemcitabine and cisplatin alone in study 1. Hypomagnesemia was
severe (grade 3 or 4) in 20% of the patients treated with Portrazza
compared to 7% of the patients treated with gemcitabine and
cisplatin alone. The median time to development of hypomagnesemia
and accompanying electrolyte abnormalities was 6 weeks (25th
percentile 4 weeks; 75th percentile 9 weeks) after initiation of
Portrazza. Monitor patients for hypomagnesemia, hypocalcemia, and
hypokalemia prior to each infusion of Portrazza during treatment,
and for at least 8 weeks following the completion of Portrazza.
Withhold Portrazza for grade 3 or 4 electrolyte abnormalities;
subsequent cycles of Portrazza may be administered in these
patients once hypomagnesemia and related electrolyte abnormalities
have improved to grade <2. Replete electrolytes as medically
appropriate.
Venous and Arterial Thromboembolic Events (VTE and
ATE)
- VTE and ATE, some fatal, were observed with Portrazza in
combination with gemcitabine and cisplatin. In study 1, the
incidence of VTE was 9% in patients receiving Portrazza plus
gemcitabine and cisplatin versus 5% in patients receiving
gemcitabine and cisplatin alone, and the incidence of grade 3 or
higher VTEs was 5% versus 3%, respectively. The incidence of fatal
VTEs was similar between arms (0.2% vs 0.2%). The most common VTEs
were pulmonary embolism (5%) and deep-vein thrombosis (2%).
- The incidence of ATEs of any grade was 5% versus 4%, and the
incidence of grade 3 or higher ATE was 4% versus 2% in the
Portrazza-containing and gemcitabine and cisplatin arms,
respectively, in study 1. The most common ATEs were cerebral stroke
and ischemia (2%) and myocardial infarction (1%). In an exploratory
analysis of study 1, the relative risk of VTE or ATE was
approximately 3-fold higher in patients with a reported history of
VTE or ATE than in patients with no reported history of VTE or ATE.
Discontinue Portrazza for patients with serious or life-threatening
VTE or ATE.
Dermatologic Toxicities
- Dermatologic toxicities, including rash, dermatitis acneiform,
acne, dry skin, pruritus, generalized rash, skin fissures,
maculo-papular rash, and erythema, occurred in 79% of patients
receiving Portrazza in study 1. Skin toxicity was severe in 8% of
patients. Skin toxicity usually developed within the first 2 weeks
of therapy and resolved within 17 weeks after onset. For grade 3
skin reactions, modify the dose of Portrazza. Limit sun exposure.
Discontinue Portrazza for severe (grade 4) skin reactions or grade
3 skin induration/fibrosis.
Infusion-Related Reactions (IRRs)
- In study 1, 1.5% of Portrazza-treated patients experienced IRRs
of any severity with 0.4% grade 3 IRRs. No patients received
premedication for IRR for the first dose of Portrazza in study 1.
Most IRRs occurred after the first or second administration of
Portrazza. Monitor patients during and following Portrazza infusion
for signs and symptoms of IRR. Discontinue Portrazza for serious or
life-threatening IRR.
Nonsquamous NSCLC—Increased Toxicity and Increased
Mortality
- Portrazza is not indicated for the treatment of patients with
nonsquamous NSCLC. In a study of Portrazza plus pemetrexed and
cisplatin (PC) versus PC alone (study 2), patients treated with
Portrazza and PC experienced more serious (51% vs 41%) and fatal
toxicities (16% vs 10%) and cardiopulmonary arrest/sudden death
within 30 days of the last study drug (3.3% vs 1.3%) compared to
patients who received PC alone.
Embryofetal Toxicity
- Based on animal data and its mechanism of action, Portrazza can
cause fetal harm when administered to a pregnant woman. Disruption
or depletion of epidermal growth factor receptor (EGFR) in animal
models results in impairment of embryofetal development, including
effects on placental, lung, cardiac, skin, and neural development.
The absence of EGFR signaling has resulted in embryolethality as
well as postnatal death in animals. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential
to use effective contraception during treatment with Portrazza and
for 3 months following the final dose.
Most Common Adverse Reactions
- Adverse reactions (all grades; grade 3/4) that occurred at an
incidence rate of >5% (all grades) or a >2% (grade 3/4)
difference between patients receiving Portrazza plus gemcitabine
and cisplatin versus gemcitabine and cisplatin alone in study 1
were rash (44% vs 6%; 4% vs 0.2%), dermatitis acneiform (15% vs
0.6%; 1% vs 0%), acne (9% vs 0.6%; 0.4% vs 0%), pruritus (7% vs
0.9%; 0.2% vs 0.2%), dry skin (7% vs 1%; 0% vs 0%), skin fissures
(5% vs 0%; 0.4% vs 0%), vomiting (29% vs 25%; 3% vs 0.9%), diarrhea
(16% vs 11%; 2% vs 1%), stomatitis (11% vs 6%; 1% vs 0.6%), weight
decreased (13% vs 6%; 0.7% vs 0.6%), hemoptysis (10% vs 5%; 1% vs
0.9%), pulmonary embolism (5% vs 2%; 4% vs 2%), headache (11% vs
6%; 0% vs 0.4%), VTE (9% vs 5%; 5% vs 3%), paronychia (7% vs 0.2%;
0.4% vs 0%), and conjunctivitis (7% vs 2%; 0.4% vs 0%).
- The most common adverse reactions (all grades) observed in
Portrazza-treated patients at a rate of >15% and >2% higher
than gemcitabine and cisplatin alone were rash (44% vs 6%),
vomiting (29% vs 25%), diarrhea (16% vs 11%), and dermatitis
acneiform (15% vs 0.6%).
- The most common severe (grade 3 or higher) adverse events that
occurred at a >2% higher rate in Portrazza-treated patients
compared to patients treated with gemcitabine and cisplatin alone
were VTE (5%; including pulmonary embolism), rash (4%), and
vomiting (3%).
- Clinically relevant adverse reactions (all grades) reported in
>1% and <5% of patients treated with Portrazza were dysphagia
(3%), oropharyngeal pain (1%), muscle spasms (2%), phlebitis (2%),
and hypersensitivity/IRRs (1.5%).
- In study 1, 12% of the patients in the Portrazza arm
discontinued study treatment due to an adverse reaction. The most
common Portrazza-related toxicity leading to Portrazza
discontinuation was skin rash (1%).
- Electrolyte abnormalities (all grades; grade 3 or 4) according
to laboratory assessment at an incidence rate of >10% and a
>2% difference between arms in patients receiving Portrazza plus
gemcitabine and cisplatin versus gemcitabine and cisplatin alone in
study 1 included hypomagnesemia (83% vs 70%; 20% vs 7%),
hypokalemia (28% vs 18%; 5% vs 3%), hypocalcemia (45% vs 30%; 6% vs
2%), albumin corrected hypocalcemia (36% vs 23%; 4% vs 2%), and
hypophosphatemia (31% vs 23%; 8% vs 6%).
- The median time to onset of hypomagnesemia was 6 weeks (25th
percentile 4 weeks; 75th percentile 9 weeks). Hypomagnesemia was
reported as resolved in 43% of the patients who received Portrazza.
In study 1, 32% of the patients in the Portrazza arm and 16% of the
patients who received gemcitabine and cisplatin alone received
magnesium replacement.
Use in Specific Populations
- Pregnancy: Based on animal data and its mechanism of
action, Portrazza can cause fetal harm when administered to a
pregnant woman. Disruption or depletion of EGFR in animal models
results in impairment of embryofetal development, including effects
on placental, lung, cardiac, skin, and neural development. The
absence of EGFR signaling has resulted in embryolethality as well
as postnatal death in animals. No animal reproduction studies have
been conducted with necitumumab. There are no available data for
Portrazza exposure in pregnant women. Advise pregnant women of the
potential risk to a fetus and the risk to postnatal
development.
- Lactation: There is no information regarding the
presence of necitumumab in human milk, the effects on the breastfed
infant, or the effects on milk production. Because of the potential
for serious adverse reactions in breastfed infants from Portrazza,
advise a nursing woman not to breastfeed during treatment with
Portrazza and for 3 months following the final dose.
- Females of Reproductive Potential: Based on its
mechanism of action, Portrazza can cause fetal harm when
administered to a pregnant woman. Advise females of reproductive
potential to use effective contraception during treatment with
Portrazza and for 3 months following the final dose.
- Geriatric Use: Of the 545 patients in the Portrazza plus
gemcitabine and cisplatin arm in Study 1, 213 (39%) were 65 years
and over, while 108 (20%) were 70 years and over. In an exploratory
subgroup analysis of study 1, the hazard ratio for overall survival
in patients 70 years or older was 1.03 (95% CI: 0.75, 1.42). Of the
adverse reactions that occurred at an incidence rate of >5% (all
grades) or a >2% (grade 3/4) difference between patients
receiving Portrazza plus gemcitabine and cisplatin versus
gemcitabine and cisplatin alone, there was a higher incidence
(>3%) of venous thromboembolic events including pulmonary
embolism in patients age 70 and over compared to those who were
younger than age 70.
Please click to access full Prescribing Information for
Portrazza, including Boxed Warnings for cardiopulmonary arrest and
hypomagnesemia at
http://pi.lilly.com/us/portrazza-uspi.pdf.
NE HCP ISI 24NOV2015
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)
PP-NE-US-0094 11/2015 © Lilly
USA, LLC 2015. ALL RIGHTS
RESERVED.
Portrazza™ is a trademark owned by or licensed to
Eli Lilly and Company, its subsidiaries, or affiliates.
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 Portrazza (necitumumab) as a
treatment of metastatic squamous non-small cell lung cancer (NSCLC)
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 Portrazza 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.
______________________
[1] Nichols, L., Saunders, R., & Knollmann, F.
(2012). Causes of Death of Patients With Lung
Cancer. Archives of Pathology & Laboratory
Medicine, 1552-1557. doi:10.5858/arpa.2011-0521-OA.
[2] Rosado-De-Christenson, M., Templeton, P., &
Moran, C. (1994). Bronchogenic carcinoma: Radiologic-pathologic
correlation. Radiographics, 14(2), 429-446.
[3] Rubin, E., & Reisner, H. (Eds.).
(2009). Essentials of Rubin's Pathology, 5th
Edition (5th ed., p. 1042). Philadelphia, PA: Lippincott Williams & Wilkins.
[4] Oliver, T., Patel, J., & Akerley, W. (2015).
Squamous Non–small Cell Lung Cancer as a Distinct Clinical
Entity. American Journal of Clinical
Oncology, 38(2), 220-226.
doi:10.1097/COC.0b013e3182a0e850.
[5] Cetin, K., Ettinger, D., & O'Malley, C.
(2011). Survival by histologic subtype in stage IV nonsmall cell
lung cancer based on data from the Surveillance, Epidemiology and
End Results Program. Clinical Epidemiology
CLEP, 3. doi:10.2147/CLEP.S17191.
[6] Baselga J. (2002) Why the epidermal growth factor
receptor? The rationale for cancer therapy. Oncologist,
7(suppl 4):2-8.
[7] Thatcher, Nick et al. (2015). Necitumumab plus
gemcitabine and cisplatin versus gemcitabine and cisplatin alone as
first-line therapy in patients with stage IV squamous
non-small-cell lung cancer (SQUIRE): an open-label, randomised,
controlled phase 3 trial. The Lancet Oncology, Volume 16,
Issue 7, 763 – 774.
[8] American Cancer Society. What is non-small cell
lung cancer? Revised March 4, 2015.
http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer.
Accessed November 13, 2015.
Refer
to:
|
Crystal
Livers-Powers; crystal_livers-powers@lilly.com; (317) 476-4160
(Lilly Oncology)
|
|
Laura Morgan;
l.morgan@togorun.com; (347) 342-8496 (TogoRun)
|
Logo -
http://photos.prnewswire.com/prnh/20031219/LLYLOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/fda-approves-portrazza-necitumumab-for-specific-type-of-lung-cancer-300184101.html
SOURCE Eli Lilly and Company