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news.AstraZeneca has reported that the Committee for Medicinal Products for Human Use, the scientific advisory committee of the European Medicines Agency, has issued a positive opinion supporting approval of the targeted oral anti-cancer drug, Iressa.
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The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Iressa 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.
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, tumor shrinkage), improved tolerability and significant quality of life benefits for Iressa compared to carboplatin/paclitaxel doublet chemotherapy in clinically selected first-line patients in Asia, said AstraZeneca.
The Interest study met its primary objective, demonstrating equivalent overall survival and significant quality of life benefits for Iressa compared to standard chemotherapy (docetaxel) in the pre-treated setting. Pre-planned sub-group analyses showed a significant improvement in PFS and ORR for Iressa over docetaxel in patients with EGFR mutation positive tumors, the company added.
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 finalize 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 EU.
Anders Ekblom, executive vice president for development at AstraZeneca, said: “Today’s positive CHMP opinion on Iressa is an important step towards addressing the great unmet medical need of lung cancer patients in Europe, and supports AstraZeneca’s personalized healthcare strategy to develop the right medicine for the right patient. If Iressa is approved, for the first time patients with these types of tumors will have a better alternative to chemotherapy as a first-line treatment.”