On December 2, 2014 AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), as identified through a companion diagnostic test (Press release AstraZeneca, DEC 2, 2014, View Source;new-drug-application-for-iressa-accepted [SID:1234501059]). The Prescription Drug User Fee Act goal date for IRESSA will be in the third quarter 2015.

IRESSA is an EGFR tyrosine kinase inhibitor that acts by blocking the transmission of signals involved in the growth and spread of tumours. AstraZeneca’s NDA submission for IRESSA was based on data from the Phase III IFUM1 (IRESSA Follow-Up Measure) clinical trial, providing evidence of IRESSA’s efficacy in Caucasian patients. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study) clinical trial, as well as other collaborative group studies.

IRESSA is already approved in 90 countries for the treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase.

On December 2, 2014 Astellas Pharma reported that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI) (Press release Astellas, DEC 2, 2014, View Source [SID:1234501049]). Enzalutamide is now approved for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.

The approval of the variation is based on results from the pivotal phase III PREVAIL study which demonstrate that enzalutamide improves outcomes for men with advanced prostate cancer who have not received chemotherapy.

Compared with placebo, enzalutamide reduced the risk of death by 29% (HR=0.71; p<0.001) and the risk of radiographic progression or death by 81% (HR=0.19; p<0.001). Men treated with enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared to placebo (28.0 months versus 10.8 months, respectively; HR=0.35; p<0.001). Astellas expects to launch enzalutamide in the pre-chemotherapy setting in the first European countries, including the UK, from January 2015. The approval of this new indication for enzaltamide triggers $45 million in milestone payments to Medivation (NASDAQ: MDVN) under its collaboration agreement with Astellas. The impact has been accounted in Astellas’ financial forecasts for fiscal year ending March 2015.