Pan European Networks - Horizon 2020 - page 199

to Norway, Iceland and Liechtenstein. The approval of olaparib was based
on data from Study 191, a Phase II clinical trial that evaluated olaparib’s
efficacy and safety compared to placebo in platinum-sensitive relapsed
high grade serous ovarian cancer patients. The study showed that
olaparib maintenance therapy significantly prolonged progression-free
survival compared with placebo in patients with BRCA-mutated ovarian
cancer. The most common adverse events associated with olaparib
monotherapy were observed as mild to moderate and included nausea,
vomiting, fatigue and anaemia.
Professor Steve Jackson, of the UK’s University of Cambridge, undertook
research to establish the basis for olaparib and its clinical potential.
Speaking about the authorisation from the European Commission,
Jackson said it was an example of how basic research and scientific
co-operation can lead to concrete benefits and clinical breakthroughs
for patients.
The scientist commented: “I look forward to learning the results of
on-going trials exploring olaparib’s potential for the treatment of other
cancers … the announcement highlights how, by collaborating with a
partner such as AstraZeneca, basic academic research, such as that
carried out by the research team at the University of Cambridge, can
lead to major medical developments.”
Adding his thoughts on the authorisation of olaparib, as well as the role
the organisation played in the breakthrough, the chief executive of Cancer
Research UK, Harpal Kumar, said: “It’s great news that the European
Commission has approved the use of olaparib within the EU, especially
when Cancer Research UK scientists played a crucial role in discovering
and developing this new generation of cancer drugs.
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number of other tumours with DNA repair
deficiencies; the drugs company says Phase
III studies are already taking place in second
line gastric cancer, BRCA-mutated pancreatic
cancer, and adjuvant and metastatic BRCA-
mutated breast cancer. Olaparib is also the first
PARP inhibitor to be approved for patients with
platinum-sensitive relapsed BRCA-mutated
ovarian cancer.
Speaking about the breakthrough, AstraZeneca’s
executive vice-president for global medicines
development and chief medical officer, Briggs
Morrison, said: “We are delighted to be able to
bring this much needed treatment to patients
with BRCA-mutated ovarian cancer, whose
options are currently very limited … approval
marks a significant milestone in the development
of the next generation of targeted medicines.
“We are committed to bringing new treatments
to the patients who need them most and …
this news marks only the first of what we hope
will be a number of indications in which
Lynparza has the potential to transform the lives
of cancer patients, including those with breast,
pancreatic and gastric cancers.”
Realising collaboration
The decision by the Commission in Brussels
applies to all 28 EU member states, in addition
AstraZeneca has
developed a new drug
to tackle a form of
BRCA-mutated
ovarian cancer
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