Novartis lung cancer drug Zykadia® gains EU approval, providing new therapy for certain patients with ALK+ NSCLC
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Novartis International AG /
Novartis lung cancer drug Zykadia® gains EU approval, providing new therapy for
certain patients with ALK+ NSCLC
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* Zykadia (ceritinib) is the first treatment option approved for patients in
Europe with ALK+ NSCLC previously treated with the ALK inhibitor crizotinib
* Marketing authorization was based on two studies demonstrating Zykadia
shrank tumors in ALK+ NSCLC patients who received prior crizotinib
therapy[1]
* Patients with brain metastases at baseline also responded to treatment, with
efficacy data comparable to those reported in the overall study
populations[1]
* Outside the EU, Zykadia is approved in ten countries including the United
States; additional regulatory filings are underway worldwide
Basel, May 8, 2015 - Novartis announced today that the European Commission has
approved Zykadia(®) (ceritinib) to treat adult patients with anaplastic lymphoma
kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously
treated with crizotinib[1]. The approval of Zykadia in the European Union (EU)
provides patients with advanced ALK+ NSCLC previously treated with crizotinib a
new treatment option that specifically targets the genetic makeup of their
cancer.
"Molecular testing for genetic drivers in lung cancer plays a critical role as
patients and physicians determine how to proceed with therapies, especially
after they have experienced disease progression following initial treatment,"
said Stefania Vallone, international relations, Women Against Lung Cancer in
Europe and board member, Lung Cancer Europe (LuCE). "Patients with resistant
ALK+ NSCLC have had very few treatment options available that specifically
target the genetic makeup of their disease. The approval of Zykadia brings new
hope to the lung cancer community as we continue to advocate for innovative
therapies."
Each year, there are 1.6 million people diagnosed worldwide with lung cancer,
the leading cause of cancer death[2]. The most common type of lung cancer is
NSCLC, accounting for 85-90% of all cases[3]. Of those, 2-7% are driven by a
rearrangement of the ALK gene, which increases the growth of cancer cells and
can be identified by a molecular test of the cancer tumor[4]. Despite
significant treatment advances for patients with ALK+ NSCLC, disease progression
is often inevitable and more treatment options are needed[5].
The EU approval of Zykadia is based on data from two global, multicenter, open-
label, single-arm studies [Study A (also known as ASCEND-1) and Study B (also
known as ASCEND-2)]. Data from Study A demonstrated patients with ALK+ NSCLC who
received Zykadia 750 mg daily after previous treatment with chemotherapy
followed by an ALK inhibitor experienced an overall response rate (ORR) of
56.4%[1]. Detailed results from Study B will be presented at an upcoming medical
congress.
"The approval of Zykadia in the European Union is significant for ALK+ NSCLC
patients who have exhausted the other treatment options for their disease," said
Bruno Strigini, President, Novartis Oncology. "This approval is yet another
example of our commitment to precision oncology and our continued focus on
developing treatment approaches that target specific genetic and molecular
characteristics of cancer."
The EU approval follows a positive opinion adopted by the Committee for
Medicinal Products for Human Use (CHMP) in February 2015 and applies to all 28
EU member states, plus Iceland, Norway and Liechtenstein. Outside the EU,
Zykadia is approved in the United States and other countries within North
America, South America, Central America and Asia. Additional regulatory reviews
for Zykadia are underway worldwide.
About the Zykadia Clinical Trials
The primary efficacy endpoint for these studies was overall response rate (ORR),
including complete response and partial response, for patients who were treated
with a 750 mg dose of Zykadia, confirmed by repeat assessments performed not
less than four weeks after the criteria for response was first met. Additional
evaluations included duration of response (DOR), progression-free survival (PFS)
and overall survival (OS). Tumor evaluations were performed according to
Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 in Study A and RECIST
1.1 in Study B. Tumor-related endpoints (ORR, DOR and PFS) were assessed by
investigator and by blinded independent review committee (BIRC). Comparative
efficacy data from randomized clinical studies are not available[1].
Study A was a Phase I study, which included a dose-escalation phase and an
expansion phase at the recommended dose of 750 mg. The study evaluated a total
of 246 ALK+ NSCLC patients who were treated with 750 mg of Zykadia: 163 had
received prior treatment with an ALK inhibitor and 83 were ALK inhibitor-naïve.
In patients who had previously received treatment with an ALK inhibitor, the ORR
was 56.4% [95% CI, 48.5-64.2%], the median DOR was 8.3 months [95% CI, 6.8-9.7
months] and the median PFS was 6.9 months [95% CI, 5.6-8.7 months] based on
investigator assessment[1].
Study B was a Phase II study designed to evaluate the efficacy and safety of
750 mg Zykadia in patients with locally advanced or metastatic ALK+ NSCLC. Study
B evaluated 140 patients who had been previously treated with one to three lines
of chemotherapy followed by treatment with crizotinib, and who had then
progressed on crizotinib[1]. Detailed results from Study B will be presented at
an upcoming medical congress.
In Studies A and B, brain metastases at baseline were seen in 60.1% and 71.4% of
patients who had received prior treatment with an ALK inhibitor, respectively.
The ORR, DOR and PFS by BIRC assessment for patients with brain metastases at
baseline were similar with those reported for the overall population of these
studies[1].
The most common adverse reactions with an incidence of >=10% were diarrhea,
nausea, vomiting, tiredness (fatigue), liver laboratory test abnormalities
(requires blood test monitoring), abdominal pain, decreased appetite,
constipation, rash, kidney laboratory test abnormalities (requires blood test
monitoring), heartburn and anemia. Grade 3-4 adverse reactions with an incidence
of >=5% were liver laboratory test abnormalities, tiredness (fatigue), diarrhea,
nausea and hyperglycemia (requires blood test monitoring)[1].
About Zykadia
Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a
gene that can fuse with others to form an abnormal "fusion protein" that
promotes the development and growth of certain tumors in cancers including non-
small cell lung cancer (NSCLC). Zykadia is approved by the European Commission
for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-
positive advanced non-small cell lung cancer (NSCLC) previously treated with
crizotinib. Outside the European Union, Zykadia is approved for patients with
ALK+ NSCLC in the United States and other countries within North America, South
America, Central America and Asia. Additional regulatory reviews for Zykadia are
underway worldwide.
Zykadia Important Safety Information
Zykadia may cause serious side effects.
Zykadia may cause stomach upset and intestinal problems in most patients,
including diarrhea, nausea, vomiting and stomach-area pain. These problems can
be severe. Patients should follow their doctor's instructions about taking
medicines to help these symptoms, and should call their doctor for advice if
symptoms are severe or do not go away.
Zykadia may cause severe liver injury. Patients should have blood tests prior to
the start of treatment with Zykadia, every two weeks for the first month of
treatment and monthly thereafter, and should talk to their doctor right away if
they experience any of the following symptoms: tiredness (fatigue), itchy skin,
yellowing of the skin or the whites of the eyes, nausea or vomiting, decreased
appetite, pain on the right side of the abdomen, urine turns dark or brown, or
bleeding or bruising more easily than normal.
Zykadia may cause severe or life-threatening swelling (inflammation) of the
lungs during treatment that can lead to death. Symptoms may be similar to those
symptoms from lung cancer. Patients should tell their doctor right away about
any new or worsening symptoms, including trouble breathing or shortness of
breath, fever, cough, with or without mucous, or chest pain.
Zykadia may cause very slow, very fast, or abnormal heartbeats. Doctors should
check their patient's heart during treatment with Zykadia. Patients should tell
their doctor right away if they feel new chest pain or discomfort, dizziness or
lightheadedness, faint, or have abnormal heartbeats, blue discoloration of lips,
shortness of breath, swelling of lower limbs or skin, or if they start to take
or have any changes in heart or blood pressure medicines.
Zykadia may cause high levels of glucose in the blood. People who have diabetes
or glucose intolerance, or who take a corticosteroid medicine have an increased
risk of high blood sugar with Zykadia. Patients should have glucose blood tests
prior to the start of treatment with Zykadia and during treatment. Patients
should follow their doctor's instructions about blood sugar monitoring and call
their doctor right away with any symptoms of high blood sugar, including
increased thirst and/or urinating often.
Before patients take Zykadia, they should tell their doctor about all medical
conditions, including liver problems; diabetes or high blood sugar; heart
problems, including a condition called long QT syndrome; if they are pregnant,
if they think they may be pregnant, or if they plan to become pregnant; are
breastfeeding or plan to breastfeed.
Zykadia may harm unborn babies. Women who are able to become pregnant must use a
highly effective method of birth control (contraception) during treatment with
Zykadia and up to 3 months after stopping Zykadia. It is not known if Zykadia
passes into breast milk. Patients and their doctor should decide whether to take
Zykadia or breastfeed, but should not do both.
Patients should tell their doctor about medicines they take, including
prescription medicines, over-the-counter medicines, vitamins and herbal
supplements. If they take Zykadia while using oral contraceptives, the oral
contraceptives may become ineffective.
The most common adverse reactions with an incidence of >=10% were diarrhea,
nausea, vomiting, tiredness (fatigue), liver laboratory test abnormalities
(requires blood test monitoring), abdominal pain, decreased appetite,
constipation, rash, kidney laboratory test abnormalities (requires blood test
monitoring), heartburn and anemia. Grade 3-4 adverse reactions with an incidence
of >=5% were liver laboratory test abnormalities, tiredness (fatigue), diarrhea,
nausea and hyperglycemia (requires blood test monitoring).
Patients should stop taking Zykadia and seek medical help immediately if they
experience any of the following, which may be signs of an allergic reaction:
* Difficulty in breathing or swallowing
* Swelling of the face, lips, tongue or throat
* Severe itching of the skin, with a red rash or raised bumps
Patients should tell their doctor of any side effect that bothers them or does
not go away. These are not all of the possible side effects of Zykadia. For more
information, patients should ask their doctor or pharmacist.
Patients should take Zykadia exactly as their health care provider tells them.
Patients should not change their dose or stop taking Zykadia unless their health
care provider advises them to. Zykadia should be taken once a day on an empty
stomach. Patients should not eat for at least 2 hours before and 2 hours after
taking Zykadia. If a dose of Zykadia is missed, they should take it as soon as
they remember. If their next dose is due within the next 12 hours, they should
skip the missed dose and take the next dose at their regular time. They should
not take a double dose to make up for a forgotten dose. Patients should not
drink grapefruit juice or eat grapefruit during treatment with Zykadia, as it
may make the amount of Zykadia in their blood increase to a harmful level. If
patients have to vomit after swallowing Zykadia capsules, they should not take
more capsules until their next scheduled dose.
Please see full Prescribing Information for Zykadia.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as " underway," "hope," "will," "commitment," "continued focus on
developing," or similar terms, or by express or implied discussions regarding
potential additional marketing approvals for Zykadia, or regarding potential
future revenues from Zykadia. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that Zykadia will be
submitted or approved for sale in any additional, or at any particular time.
Neither can there be any guarantee that Zykadia will be commercially successful
in the future. In particular, management's expectations regarding Zykadia could
be affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; the uncertainties inherent in research and
development, including unexpected clinical trial results and additional analysis
of existing clinical data; the company's ability to obtain or maintain
proprietary intellectual property protection; general economic and industry
conditions; global trends toward health care cost containment, including ongoing
pricing pressures; unexpected manufacturing issues, and other risks and factors
referred to in Novartis AG's current Form 20-F on file with the US Securities
and Exchange Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2014, the Group achieved net
sales of USD 58.0 billion, while R&D throughout the Group amounted to
approximately USD 9.9 billion (USD 9.6 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 120,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please
visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Zykadia(®) (ceritinib) Summary of Product Characteristics. Basel,
Switzerland: Novartis Pharma AG; 06-May-2015.
[2] Jemal A, et al. Global cancer statistics. CA Cancer J Clin. 2011;61:69-90.
[3] American Cancer Society. Detailed Guide: Lung Cancer (Non-Small Cell).
Available at http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-
pdf.pdf. Accessed March 2015.
[4] National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer. NCCN
2014 3:1-148.
[5] Katayama R, Shaw AT, Khan TM, et al. Mechanisms of acquired crizotinib
resistance in ALK-rearranged lung cancers. Sci Transl Med. 2012;4(120):1-12.
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Datum: 08.05.2015 - 07:15 Uhr
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