Targeted therapy agent for lung cancer to be introduced in UAE soon

Published May 17th, 2009 - 07:18 GMT

AstraZeneca announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific advisory committee of the European Medicines Agency (EMEA), had issued a positive opinion supporting approval of the targeted oral anti-cancer drug, (Gefitinib).

Two leading local oncologists have said that a new chapter in lung cancer treatment in the UAE will be opened with the introduction of the drug (Gefitinib), as an effective option to chemotherapy, giving patients a better quality of life by lowering the side effects of chemotherapy.  Another oncologist said the drug comes at a time when lung cancer is on the rise in the UAE and there is a low awareness of the severe effect of smoking including shisha.

Dr. Shaheena Dawood, Senior Oncologist, Dubai Hospital, Dubai Healthcare Authority, speaking at a press conference to unveil a recent study on lung cancer treatment, said: "Sixty per cent of lung cancer patients in Dubai Hospital are smokers. Results of this study speak for themselves. The fact that (Gefitinib) got approval so quickly is very important. The next move is to disseminate the results of this study amongst the community of oncologists in the UAE and GCC, so that they are aware about the options.  It is also very important to educate the patients to make informed decisions. Targeted therapy is more convenient than chemotherapy and it has fewer side effects.

The CHMP has recommended the approval of Gefitinib for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase), in all lines of therapy.

Dr. Dawood continued: “Lung cancer is often detected when it is at advanced stages and this underlines the importance of I(Gefitinib), as a first line treatment where the ability to tolerate treatment reduces substantially with progression of the disease. This news is very important as it shows the importance of using medical science in conducting studies with due diligence. Dr. Dawood said that the fast-paced lifestyle of UAE residents was contributing to rising incidence of lung cancer”.

Dr Mohammed Jaloudi, Chief of Medical Oncology, Tawam Hospital said: "As more young people have started smoking, lung cancer can take alarming proportions in 15 years, though it is not yet among the top three cancer killers here.  We do urge banning smoking in all public areas and raising awareness about its bad effects. There are not enough studies about the bad effect of Shisha but there is enough evidence that it can lead to lung cancer.”

“There were 70 cases of lung cancers in 2008 nationwide. This new drug is a significant weapon to fight lung cancer. Shisha, smoking and aging increase the risk of lung cancer," Dr. Jaloudi added.

Gefitinib acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. A mutation in the EGFR is a characteristic occurring in 10-15% of lung cancers in Europe, and studies have shown that these types of tumours are particularly sensitive to Gefitinib. There are approximately 106,000 new cases of advanced lung cancer in Europe (top 5 countries) per year.

Dr. Khalid Shirazy, Medical Director, AstraZeneca Gulf, said: "Today’s positive CHMP opinion on Gefitinib is an important step towards addressing the great unmet medical need of lung cancer patients in Europe, and supports AstraZeneca’s personalised healthcare strategy to develop the right medicine for the right patient. If Gefitinib is approved, for first-time patients with these types of tumours we will have a better alternative to chemotherapy as a first-line treatment.”

The CHMP opinion is based on a submission package including two pivotal Phase III studies, IPASS and INTEREST.

The IPASS study exceeded its primary objective, demonstrating superior progression-free survival (PFS, the time a patient lives without their cancer progressing), greater objective response rate (ORR, tumour shrinkage), improved tolerability and significant quality of life benefits for Gefitinib compared to carboplatin/paclitaxel doublet chemotherapy in clinically selected first-line patients in Asia. However, the treatment effect was not constant over time, with the probability of being progression-free in favour of carboplatin/paclitaxel in the first 6 months and in favour of Gefitinib in the following 16 months. This was likely due to the different effect of Gefitinib in subgroups defined by EGFR tumour mutation status. PFS was significantly longer for Gefitinib than doublet chemotherapy in patients with EGFR mutation positive tumours, and significantly longer for doublet chemotherapy than Gefitinib in patients with EGFR mutation negative tumours.

The INTEREST study met its primary objective, demonstrating equivalent overall survival (OS) and significant quality of life benefits for Gefitinib compared to standard chemotherapy (docetaxel) in the pre-treated setting. Pre-planned sub-group analyses showed a significant improvement in PFS and ORR for Gefitinib over docetaxel in patients with EGFR mutation positive tumours.

AstraZeneca will be required to conduct a Follow-up Measure Study, to generate further data in a Caucasian NSCLC patient population.  AstraZeneca is in discussion with the CHMP to finalise the study design and endpoints.

The CHMP positive opinion is now referred for final action to the European Commission, which grants marketing approval in the European Union.

Gefitinib is already an established therapy for pre-treated NSCLC in the Asia-Pacific region, where AstraZeneca is in consultation with regulatory authorities to discuss the potential use of Gefitinib in first-line therapy.


In 2005, AstraZeneca withdrew its EU marketing authorisation application for Gefitinibfollowing data from the Phase III international ISEL study in pre-treated patients not eligible for further chemotherapy. ISEL did not meet its primary objective of a statistically significant improvement in OS for Gefitinib compared to placebo, but did confirm a number of important clinical benefits for Gefitinib including tumour shrinkage and a significant improvement in time to treatment failure. The refractory* nature of the ISEL population is the most likely explanation for the magnitude of the survival improvement with Gefitinib compared to placebo not reaching statistical significance.

* Patients whose tumours had grown during or soon after receiving prior chemotherapy

Following delivery of the INTEREST data, AstraZeneca submitted a new regulatory package to the EMEA in May 2008; the IPASS data were added to the submission package when they became available in Q3 2008.

There is a rolling programme of approvals and licence updates for Gefitinib around the world in a broad second-line population based on data from the INTEREST study.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines.

For more information about AstraZeneca, please visit: www.astrazeneca.com

 


 


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