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AstraZeneca Obtains
Approval for Iressa The
World's First with the Fastest Speed
AstraZeneca（Head office： Kita-ku, Osaka-shi, President：
Martin Wright）received import approval for Iressa
on July 5, 2002 from the Ministry of Health, Labor and Welfare for the indication
of inoperable and recurrent non-small cell lung cancer.
The first indication for Iressa
is for the treatment of non-small cell lung cancer and is under global development
by AstraZeneca for further indications. In Japan, the non-small cell lung cancer
NDA was submitted on January 25, and the approval was granted with the fastest
speed ever except for anti-AIDS drugs. Approval has been given a little more than
five months after the submission, and therefore Japan has become the first country
of approval in the world. Also, Iressa represents the first case of Japan being
the first to approve any globally developed product worldwide. This 'landmark'
achievement was made possible by the enhanced efficiency of the review itself
which is the result of the improvement of NDA Review system and process, the Priority
Review given in consideration of the efficacy and medical needs of Iressa,
and AstraZeneca's uniquely innovative new drug development approach which enables
the company to conduct simultaneous development and NDA filing in Japan-US-Europe.
This new approach is possible due to the introduction of the ICH guidelines and
development strategy.
Iressa（once
daily, orally active）is one of the new molecular targeted agents which are different
from conventional anti-cancer drugs, and is the first selective EGFR-TKI（epidermal
growth factor receptor-tyrosine kinase inhibitor）approved in the world. As the
molecular targeted agent at the forefront of cancer treatment, Iressa
is expected to broaden options for non-small cell lung cancer treatment. The JNDA
of Iressa
was filed based on the data from two Phase II studies. The data demonstrated that
Iressa
250mg/day once daily monotherapy caused reduction in tumor size or disease stabilization,
and improvement of subjective symptoms associated with the disease, in patients
with advanced non-small cell lung cancer who had failed on previous treatments.
Unlike conventional chemotherapeutic agents, the side effects reported were generally
mild to moderate and included skin rash and diarrhea. One of the Phase II studies
mentioned above was an international clinical trial conducted at Japanese and
European medical institutions using the same protocol involving some 200 patients,
including 102 Japanese patients.
The number of deaths caused by cancer has been increasing year after year, and
since 1981, cancer has been the no. 1 cause of deaths in Japan for the past 21
consecutive years. In 2001, three hundred thousands and five hundred eighty-six（300,586）individuals
died of cancer（the total number of deaths was 970,313）. Moreover, lung cancer,
of which about 55,000 died in 2001, has been at the top of the causes of cancer
deaths since 1998, and the number is expected to continue to increase in the future.
We plan to launch Iressa
upon NHI Price Listing. However, patients eligible for Iressa
have advanced non-small cell lung cancer, their prognosis is poor, and the tumours
progress rapidly, and waiting two months for reimbursement may be too long for
some of these patients. It is because of this significant patient need and strong
requests from both patients and doctors that we have decided to make Iressa
available under the Special Healthcare Exemption system from the middle of July.
We are confident that Iressa
will provide symptomatic improvement and disease stabilization to lung cancer
patients and contribute to improvement of their QOL（Quality of Life）. |
