Launch of Highly Targeted Cancer Treatment Tasigna(R) (nilotinib) Offers Potential Lifeline to Ph+ CML Patients Intolerant or Resistant to Existing Therapies, Including Glivec(R) (imatinib)
FRIMLEY, England, May 20/PRNewswire-FirstCall/ --
- Tasigna(R) (nilotinib) Effective in 77% of Patients Resistant or
Intolerant to Prior Treatment in the Chronic (Early) Phase of Chronic Myeloid
Leukaemia (CML)(1)
- Highly Targeted Nature of Tasigna(R) Tackles the Root Cause of CML
Whilst Providing an Acceptable Tolerability Profile for Patients(1)(2)
- Tasigna Expands CML Portfolio for Novartis, Providing Effective
Treatment Options for the Majority of Patients With Tasigna(R) and the CML
Gold-Standard, Glivec(R)(imatinib)
Tasigna(R) (nilotinib) is now available in the UK as a new option to
treat adult patients who are intolerant or resistant to previous therapies
for Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML).
The availability of Tasigna(R) means that the majority of patients with CML
can now be effectively treated, even those who did not respond to or cannot
tolerate previous therapies including Glivec(R) (imatinib).
Data that led to the European approval of Tasigna(R) show that 77% of
patients who had no haematological response when they started taking
Tasigna(R) achieved a complete haematological response with the drug (ie.
blood cell counts returned to normal)(1); Furthermore 40% of patients
achieved a complete cytogenic response(1) (meaning that no abnormal
chromosomes, the root cause of CML, are detected in the bone marrow
cells)(1). At 12 months the overall survival rate was 95%(1).
Based on the success of the current gold standard treatment for CML,
Glivec(R) (imatinib), also made by Novartis, scientists developed Tasigna(R)
to more specifically target the cause of CML (Bcr-Abl). Other newer
treatments for CML have a broad mechanism of action which can lead to
increased side effects. The highly targeted nature of Tasigna(R) means that
it has a positive tolerability profile(2) and few patients who suffered side
effects from other therapies suffered the same significant side effects with
Tasigna(R)(2).
Tasigna(R) works quickly in patients who have undergone other therapies,
laboratory trials have shown it is effective in 32 out of 33 known imatinib
resistant mutant cell lines.(3)
Tasigna trialist, Professor Richard Clark, Consultant Haematologist at
Royal Liverpool University Hospital said:
"Running out of treatment options is a terrible scenario for any patient
with CML, a disease where the prognosis has not always been good. The arrival
of Tasigna(R) is a major step forward for those patients that do not respond
to existing treatments. To be able to offer patients a reliable and effective
option with a good safety profile is a significant advance in the treatment
of CML."
CML is one of the four most common leukaemias in the world affecting 4000
people in the UK(4) Most people with CML can be treated in the long term with
Glivec (imatinib) but a small amount of people, estimated at 3% per year
cannot take Glivec(R) because of intolerance or because their cancer mutates
and becomes resistant to Glivec(R)(5) Tasigna(R) offers an effective and well
tolerated treatment option to the majority of people with imatinib resistant
CML.
Sandy Craine, CML Support UK, welcomes the launch of Tasigna:
"Tasigna is an important advance as it provides an effective treatment
option for the small number of CML patients who develop resistance to or are
intolerant of Glivec. Glivec signified a revolution in the way we think about
treating cancers and has proven to be very effective in the long term.
Tasigna offers patients resistant or intolerant to previous therapies the
chance to regain control of their health and continue to live normal and
productive lives."
References
(1). Kantarjian, H et al. Nilotinib is Highly Active and Safe in Chronic
Phase Chronic Myelogenous Leukemia (CML-CP) Patients with Imatinib-resistance
or Intolerance. Oral Presentation. American Society of Hematology Annual
Meeting, 2007. Abstract #735.
(2). Cortes, J et al. Nilotinib is associated with minimal cross
intolerance to imatinib in patients with imatinib intolerant Philadelphia
chromosome positive CML in either chronic phase or accelerated phase. Oral
presentation. American Society of Haematology Annual meeting. 2007. Abstract
# 1040.
(3). Kantarjian, H et al. Nilotinib in Imatinib-Resistant CML and
Philadelphia Chromosome-Positive ALL. N Engl J Med. 354, no. 24 (2006).
(4). CancerBackup, Nice one - CancerBACUP welcomes decision on treatment
for leukaemia
http://www.cancerbackup.org.uk/News/Mediacentre/Pressreleasesstatements/
2002/4352
(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)
Last accessed 28 April 2008
(5). Hochhaus, A et al. IRIS 6-Year Follow-Up: Sustained Survival and
Declining Annual Rate of Transformation in Patients with Newly Diagnosed
Chronic Myeloid Leukaemia in Chronic Phase (CML-CP) Treated with Imatinib.
Oral presentation. Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 25
Notes to editors
About Tasigna(R) (nilotinib)
Taken orally, twice daily, nilotinib works by inhibiting the
proliferation of cells containing an abnormal chromosome. It does this by
targeting the production of the Bcr-Abl protein, which is produced only by
cells containing the abnormal Philadelphia chromosome. This protein is
recognised as the key driver of the overproduction of cancer cells in
patients with Ph+ CML.
Applying experience gained from the development of Glivec(R),
a team of Novartis scientists created nilotinib in August 2002, just a year
after the launch of Glivec(R). In preclinical studies, the medicine was able
to overcome resistance resulting from Bcr-Abl kinase mutations in 32 of 33
imatinib resistant mutant cell lines. Patients with a variety of these
mutations also responded to treatment with nilotinib. Nilotinib was
specifically designed to target the Bcr-Abl protein more preferentially than
Glivec(R), without adding new mechanisms of action.
Nilotinib was approved in Switzerland in July 2007, followed by approvals
by the U.S. Food and Drug Administration (FDA) and the European Commission in
November 2007. Nilotinib was also submitted for approval in Japan in June
2007.
About Glivec(R) (Imatinib)
Glivec(R) is approved in more than 90 countries including the US, EU and
Japan for the treatment of all phases of Ph+ CML. Glivec is also approved in
the EU, US and other countries for the treatment of patients with Kit
(CD117)-positive gastrointestinal tumours (GIST), which cannot be surgically
removed and/or have already spread to other parts of the body (metastasized).
In Japan, Glivec(R) is approved for the treatment of patients with Kit
(CD117)-positive GIST. In the EU, Glivec(R) is also approved for the
treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic
leukaemia (Ph+ ALL) in combination with chemotherapy and as a single agent
for patients with relapsed or refractory Ph+ ALL. Glivec(R) is also approved
for the treatment of adult patients with unresectable, recurrent and/or
metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for
surgery. Glivec(R) is also approved for the treatment of patients with
myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec(R) is also
approved for hypereosinophilic syndrome and/or chronic eosinophilic leukaemia
(HES/CEL).
The effectiveness of Glivec(R) is based on overall haematologic and
cytogenetic response rates and progression-free survival in CML, on
haematological and cytogenetic response rates in Ph+ ALL and on objective
response rates in GIST and DFSP.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering
medicines to protect health, cure disease and improve well-being. Our goal is
to discover, develop and successfully market innovative products to treat
patients, ease suffering and enhance the quality of life. We are
strengthening our medicine-based portfolio, which is focused on strategic
growth platforms in innovation-driven pharmaceuticals, high-quality and
low-cost generics, human vaccines and leading self-medication OTC brands.
Novartis is the only company with leadership positions in these areas. In
2006, the Group's businesses achieved net sales of USD 37.0 billion and net
income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 100,000 associates and operate in over 140 countries around the
world. For more information, please visit http://www.novartis.com.
Source: Novartis Pharmaceuticals UK Ltd
For more information, please contact: Novartis Pharmaceuticals UK Ltd, Tel: +44(0)1276-698086, Fax: +44(0)1276-698605, Email: fiona.turner@novartis.com; Pip Rogan / James HumphreysRed Health, Tel: +44(0)207-025-6566 / +44(0)207-025-6522, Fax: +44(0)207-025-6499, Email: pip.rogan@redconsultancy.com / james.humphreys@redconsultancy.com
2008-05-19 19:04:15 0365764 PRNEWSWIRE