Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib
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Novartis International AG /
Novartis lung cancer drug Zykadia® recommended for EU approval in patients with
ALK+ NSCLC previously treated with crizotinib
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* If approved, Zykadia (ceritinib) would be the first treatment option for
patients in Europe with ALK+ NSCLC previously treated with crizotinib
* ALK+ NSCLC is driven by a rearrangement of the ALK gene, which is
responsible for cancer cell growth in 2-7% of patients with NSCLC[1]
* Positive CHMP opinion represents a critical milestone for Zykadia; now
approved in several countries worldwide, with additional regulatory filings
underway
Basel, February 27, 2015 - Novartis announced today that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted
a positive opinion for Zykadia(®) (ceritinib) to treat adult patients with
anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer
(NSCLC) previously treated with crizotinib[2]. If approved in the European Union
(EU), Zykadia will be the first treatment option to address an unmet medical
need for patients with ALK+ NSCLC previously treated with crizotinib.
"Patients with advanced ALK+ NSCLC have few options when their cancer does not
respond to currently approved therapy," said Alessandro Riva, MD, Global Head,
Novartis Oncology Development and Medical Affairs. "As a leader in the
development of precision oncology medicines, Novartis is committed to developing
and bringing to market new treatments for patients with ALK+ NSCLC. This
positive CHMP opinion for Zykadia brings us one step closer to providing the
lung cancer community with new hope in the fight against this terrible disease."
Each year, there are 1.6 million people diagnosed with lung cancer, the leading
cause of cancer death worldwide[3]. The most common type of lung cancer is
NSCLC, accounting for 85-90% of all cases[4]. 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[1]. Despite
significant treatment advances for patients with ALK+ NSCLC, disease progression
is often inevitable and more treatment options are needed[5].
In the EU, the European Commission generally follows the recommendations of the
CHMP and delivers its final decision within three months of the CHMP
recommendation. The decision will be applicable to all 28 EU member states plus
Iceland, Norway and Liechtenstein. Zykadia is currently approved in the United
States, Mexico, Chile, South Korea, Guatemala and Ecuador. Additional regulatory
reviews are underway in North America, South America, Central America and Asia.
The CHMP recommendation for Zykadia was based on results from two global,
multicenter, open-label, single-arm studies (Study A and Study B). Comparative
efficacy data from randomized clinical studies are not yet available. 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) and progression-free survival
(PFS) by investigator and blinded independent review committee (BIRC)
assessment, 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[2].
About the Zykadia Clinical Trials
Study A was a Phase I study that 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[2].
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 involved 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[2].
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[2].
The most common adverse reactions with an incidence of >=10% were diarrhea,
nausea, vomiting, tiredness (fatigue), liver function test abnormalities
(require blood test monitoring), abdominal pain, decreased appetite,
constipation, rash, kidney function test abnormalities (require blood test
monitoring), heartburn and anaemia. Grade 3-4 adverse reactions with an
incidence of >=5% were liver function test abnormalities, tiredness (fatigue),
diarrhea, nausea and hyperglycemia[2].
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 currently approved in the United
States, Mexico, Chile, South Korea, Guatemala and Ecuador to treat adult
patients with ALK+ NSCLC. Additional regulatory reviews are underway in North
America, South America, Central America and Asia.
In the European Union, Zykadia (ceritinib) is an investigational agent and has
not been approved by regulatory authorities.
Zykadia Important Safety Information
Zykadia may cause serious side effects.
Zykadia causes stomach and intestinal problems in most people, 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,
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 level 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 whilst 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 function test abnormalities
(require blood test monitoring), abdominal pain, decreased appetite,
constipation, rash, kidney function test abnormalities (require blood test
monitoring), heartburn and anaemia. Grade 3-4 adverse reactions with an
incidence of >=5% were liver function test abnormalities, tiredness (fatigue),
diarrhea, nausea and hyperglycemia.
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 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 "recommended," "would," "positive CHMP opinion," "milestone,"
"underway," "positive opinion," "will," "can," "committed," "one step closer,"
"hope," "generally follows," "recommendations," "ongoing," "investigational," or
similar terms, or by express or implied discussions regarding potential
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 approved for sale in
any market, or submitted for approval in any additional markets, 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, cost-saving generic pharmaceuticals, preventive vaccines and over-the-
counter products. Novartis is the only global company with leading positions in
these areas. In 2014, the Group achieved net sales of USD 58 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 130,000 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] National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer. NCCN
2014 3:1-148.
[2] Zykadia® (ceritinib) Summary of Product Characteristics. Basel, Switzerland:
Novartis Pharma AG; February 2015.
[3] Jemal A, et al. Global cancer statistics. CA Cancer J Clin. 2011;61:69-90.
[4] 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 February 2015.
[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: 27.02.2015 - 13:23 Uhr
Sprache: Deutsch
News-ID 374905
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