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First-Line Chemotherapy Regimen Showed Clinically Relevant Survival Differences in Specific Histology Types of Advanced Non-Small Cell Lung Cancer INDIANAPOLIS, Sept. 29
INDIANAPOLIS, Sept. 29 /PRNewswire-FirstCall/ --
Eli Lilly and Company
(NYSE: LLY) announced today it received approval from the U.S. Food and Drug
Administration (FDA) for the use of ALIMTA(R) (pemetrexed for injection), in
combination with cisplatin, in the first-line treatment of locally-advanced
and metastatic non-small cell lung cancer (NSCLC), for patients with
nonsquamous histology. ALIMTA is not indicated for treatment of patients with
squamous cell non-small cell lung cancer. NSCLC is the most common form of
lung cancer, resulting in more than 180,000 new cases in the U.S. each
year.(1,2)
NSCLC is defined as a group of histologies, that is, tumor types
differentiated by cellular structure. Nonsquamous histology includes
adenocarcinoma, large cell carcinoma and all other histologies except squamous
cell carcinoma.
This marks the third U.S. indication for ALIMTA. In 2004, ALIMTA received
consecutive approvals: first in combination with cisplatin as a treatment for
patients with malignant pleural mesothelioma, whose disease is unresectable or
who are otherwise not candidates for curative surgery, and then as a single
agent for the second-line treatment of patients with locally-advanced or
metastatic NSCLC after prior chemotherapy treatment.(3)
The ALIMTA approval in first-line advanced NSCLC for nonsquamous cell
histology is based on a Phase III, open-label randomized study (1725 patients)
that evaluated ALIMTA plus cisplatin (AC arm) versus GEMZAR(R) (gemcitabine
HCl for injection) plus cisplatin (GC arm). The median survival was 10.3
months in the AC arm and 10.3 months in the GC arm [adjusted hazard ratio 0.94
(95% CI: 0.84, 1.05)]. The median progression-free survival was 4.8 and 5.1
months for the AC and GC arms, respectively [adjusted hazard ratio 1.04 (95%
CI: 0.94, 1.15)]. The overall response rates were 27.1% and 24.7% for the AC
and GC arms, respectively.
In a pre-specified analysis, the impact of NSCLC histology on overall
survival was examined. Clinically relevant differences in survival according
to histology were observed. In the nonsquamous cell NSCLC subgroup, the median
survival was 11.0 and 10.1 months in the AC and GC groups, respectively
[unadjusted hazard ratio 0.84 (95% CI: 0.74, 0.96)]. However, in the squamous
cell histology subgroup, the median survival was 9.4 versus 10.8 months in the
AC and GC groups, respectively [unadjusted hazard ratio 1.22 (95% CI: 0.99,
1.50)].(4) This unfavorable effect on overall survival associated with
squamous cell histology observed with pemetrexed was also noted in a
retrospective analysis of the single-agent trial of pemetrexed versus
docetaxel in patients with stage III/IV NSCLC after prior chemotherapy.(5)
Patients treated with the ALIMTA regimen had less hematologic toxicity,
fewer blood transfusions and decreased use of growth factors compared to those
treated with the GEMZAR regimen. The most common adverse reactions (incidence
greater than or equal to 20%) for ALIMTA in combination with cisplatin
included vomiting, neutropenia, leukopenia, anemia, stomatitis/pharyngitis,
thrombocytopenia and constipation.
Based on the same data, the FDA also approved a change to the second-line
indication. ALIMTA is indicated as a single agent for the treatment of
patients with locally-advanced or metastic nonsquamous non-small cell lung
cancer after prior chemotherapy. ALIMTA is not indicated for treatment of
patients with squamous cell non-small cell lung cancer.
For full prescribing and safety information about ALIMTA, visit
www.ALIMTA.com.
Notes to Editor
About Non-Small Cell Lung Cancer (NSCLC)
NSCLC is the most common type of lung cancer and represents 85 to 90
percent of all lung cancers.(6) NSCLC has five-tier staging, starting at 0
and rising to the severity of stage IV.(7) NSCLC can spread through the
lymphatic system, penetrating the chest lining, ribs, and the nerves and blood
vessels that lead to the arm. The liver, bones and brain are potential
targets if the cancerous cells enter the bloodstream.
According to the World Health Organization (WHO) Cancer Report, lung
cancer is the world's most common cancer and the leading cause of cancer death
for men and women. More than 1 million people die from lung cancer each
year.(8)
NSCLC is defined as a group of histologies, that is, tumor types
differentiated by cellular structure. The most common NSCLC histology types
are squamous carcinoma, adenocarcinoma and large cell carcinoma.(9)
About Lilly Oncology, a Division of Eli Lilly and Company
For more than four decades, Lilly Oncology has been dedicated to
delivering innovative solutions that improve the care of people living with
cancer. Because no two cancer patients are alike, Lilly Oncology is committed
to developing novel treatment approaches. Our quest is to develop a broad
portfolio of tailored therapies that accelerate the pace and progress of
cancer care. To learn more about Lilly's commitment to cancer, please visit
www.LillyOncology.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs.
P-LLY
ALIMTA(R) (pemetrexed for injection), Lilly
GEMZAR(R) (gemcitabine HCl for injection), Lilly
This press release contains forward-looking statements about the potential
of ALIMTA and GEMZAR for the treatment of non-small cell lung cancer and
reflects Lilly's current beliefs. However, as with any pharmaceutical product
under development, there are substantial risks and uncertainties in the
process of development, commercialization, and regulatory review. There is no
guarantee that the products will receive additional regulatory approvals.
There is also no guarantee that the products will continue to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's filings with the United States Securities and
Exchange Commission. Lilly undertakes no duty to update forward-looking
statements.
Important Safety Information for ALIMTA
ALIMTA is approved by the FDA in combination with cisplatin (another
chemotherapy drug) for the initial treatment of advanced nonsquamous non-small
cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated
for patients who have a different type of NSCLC called squamous cell.
ALIMTA is approved by the FDA as a single agent (used alone) for the
treatment of patients with advanced nonsquamous non-small cell lung cancer
(NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not
indicated for patients who have a different type of NSCLC called squamous
cell.
ALIMTA is a treatment for Malignant Pleural Mesothelioma (MPM), which is a
cancer that affects the inside lining of the chest cavity. ALIMTA is given
with cisplatin, another anti-cancer medicine (chemotherapy) when surgery is
not an option.
Myelosuppression is usually the dose-limiting toxicity with ALIMTA
therapy.
ALIMTA may not be appropriate for some patients. If you are allergic to
ALIMTA, tell your doctor because you should not receive it. If you think you
are pregnant, are planning to be pregnant, or are nursing, please tell your
healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician
may advise you to use effective contraception (birth control) to prevent
pregnancy while you are being treated with ALIMTA.
If you have liver or kidney problems, be sure to tell your doctor. Your
dose of ALIMTA may have to be changed, or ALIMTA may not be right for you.
There is a risk of side effects associated with ALIMTA therapy. ALIMTA can
suppress bone marrow function. It is very important to take folic acid and
vitamin B12 prior to and during your treatment with ALIMTA to lower your
chances of harmful side effects.
Your healthcare professional will prescribe a medicine called a
corticosteroid, which lowers your chances of getting skin reactions with
ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs
(nonsteroidal anti-inflammatory drugs used to treat pain or swelling). Tell
your doctor if you are taking other medicines, including prescription and
non-prescription medicines, vitamins, and herbal supplements.
The most common side effects of ALIMTA when given alone or in combination
with cisplatin, another chemotherapy drug, are low blood cell counts (red
blood cells, white blood cells, and platelets); tiredness; stomach upset,
including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of
appetite; rash; and constipation.
Call your healthcare professional right away if you have a fever, chills,
diarrhea, or mouth sores. These symptoms could mean you have an infection.
These are not all of the side effects of ALIMTA. If you have any side effect
that bothers you or that doesn't go away, be sure to talk with your healthcare
professional.
You will have regular blood tests before and during your treatment with
ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment
based on the results of your blood test and on your general condition.
For more information about all of the side effects of ALIMTA, please talk
with your healthcare team, see the complete Prescribing Information at
www.ALIMTA.com, or call 1-800-545-5979.
Important Safety Information for GEMZAR
GEMZAR is indicated in combination with cisplatin (another type of
chemotherapy) for the first-line treatment of patients with locally advanced
(stage IIIA or stage IIIB) or metastatic (stage IV or cancer that has spread)
non-small cell lung cancer for whom surgery is not possible.
Myelosuppression is usually the dose-limiting toxicity with GEMZAR
therapy.
GEMZAR may not be appropriate for some patients. If you are allergic to
GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone
marrow function. There have been rare reports of serious kidney or liver
toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has
also been reported, sometimes fatal. If you think you are pregnant, are
planning to be pregnant, or are nursing, please tell your healthcare team.
GEMZAR may harm your unborn or nursing baby.
If you have had prior kidney or liver problems or impairment, please tell
your healthcare professional. GEMZAR may not be right for you. GEMZAR has not
been shown to work in children. Tell your doctor if you are taking other
medicines, including prescription and non-prescription medicines, vitamins, or
herbal supplements.
There is a risk of side effects associated with GEMZAR therapy. The most
common side effects are low blood cell counts (red blood cells, white blood
cells, and platelets); fever; infection; hair loss; tiredness; nausea,
vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches;
and numbness or tingling in your toes or fingers. These are not all of the
side effects of GEMZAR. If you have any side effect that bothers you or that
doesn't go away, be sure to talk with your healthcare professional. Call your
healthcare professional right away if you have fever or chills. These symptoms
could mean you have an infection.
You will have regular blood tests before and during your treatment with
GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment
based on the results of your blood test and on your general condition.
For more information about all of the side effects of GEMZAR, please talk
with your healthcare team, see the complete Prescribing Information at
www.GEMZAR.com, or call 1-800-545-5979.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
(1) American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-
Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).
(2) American Cancer Society, "What Are the Key Statistics About Lung
Cancer?," October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statisti
cs_About_Lung_Cancer_15.asp?rnav=cri, (September 19, 2008).
(3) NOTE: The 2nd-line NSCLC indication was approved under 21 CFR 314.500
et seq (Subpart H - Accelerated Approval of New Drugs for Serious or
Life-Threatening Illnesses) using a surrogate endpoint.
(4) Scagliotti G, Vittorio P, et al. Phase III Study Comparing Cisplatin
Plus Gemcitabine With Cisplatin Plus Pemetrexed in Chemotherapy-Naive Patients
With Advanced-Stage Non-Small-Cell Lung Cancer; J Clin Oncol 2008 26: 3543-
3551.
(5) Peterson P, Park K, et al. Is pemetrexed more effective in patients
with non-squamous histology? A retrospective analysis of a phase III trial of
pemetrexed vs docetaxel in previously treated patients with advanced nonsmall
cell lung cancer (NSCLC). Abstract P#6521, The European Cancer Conference 2007
(ECCO 14). European Journal of Cancer Supplements, Vol 5 No 4, Page 363.
(6) American Cancer Society, "What Is Non-Small Cell Lung Cancer?,"
October 15, 2007, American Cancer Society,
http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-
Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).
(7) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?"
October 15, 2007, American Cancer Society,
www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-
Small_Cell_Lung_Cancer_Staged.asp?rnav=cri, (February 21, 2008).
(8) World Health Organization, Gender in Lung Cancer and Smoking
Research, Department of Gender, Women and Health, 2003,
http://www.who.int/gender/documents/en/lungcancerlow.pdf.
(9) National Cancer Institute, "Non-Small Cell Lung Cancer Treatment
(PDQ(R)) Health Professional Version," December 14, 2007, National Cancer
Institute,
www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-
lung/HealthProfessional/page2, (February 14, 2008).
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SOURCE Eli Lilly and Company