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US FDA grants priority review to Afatinib


Boehringer Ingelheim has announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the US Food and Drug Administration (FDA).
The application for afatinib is currently under review for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation as detected by an FDA-approved test. The FDA target action date for afatinib will be in the third quarter of 2013.
Afatinib has demonstrated a significant delay in tumour growth versus the best-in-class chemotherapy, which resulted in 11.(1) months progression free survival (PFS) vs. 6.9 months in the comparator arm. Afatinib is currently under review by the European Medicines Agency (EMA) following submission for Marketing Authorisation in Europe in August 2012.(1)
“The acceptance of the NDA filing reinforces our ongoing commitment to oncology as we take the necessary steps to seek approval for our first cancer treatment, in an area of high unmet medical need,” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “We are excited that the positive clinical data for afatinib is now currently under review by both the FDA and EMA and look forward to working diligently with both agencies in the hope that people with lung cancer can soon benefit from this new treatment.”
The NDA submission is based on the comprehensive LUX-Lung clinical trial programme. Data from the pivotal LUX-Lung 3 trial, comparing afatinib to pemetrexed and cisplatin, considered best-in-class chemotherapy for non squamous NSCLC,(2) demonstrated superiority in progression-free survival (PFS) in patients with stage IIIb or IV adenocarcinoma of the lung harbouring an EGFR mutation. Patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing (PFS of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed / cisplatin).(1) Importantly, patients taking afatinib with the most common EGFR mutations (del19 and L858R, accounting for 90% of all EGFR mutations) lived for well over a year without progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.(1)
In addition, patients treated with afatinib experienced better and longer control and improvement of the most common lung cancer-related symptoms and better quality of life (QoL) compared to chemotherapy (pemetrexed and cisplatin). Importantly, afatinib treatment led to improved physical, role and cognitive functioning, and overall better QoL.(3)
The most common adverse events associated with afatinib treatment were diarrhoea and rash/acne. These adverse events were as expected with EGFR inhibition, consistent with previous studies, and were manageable and reversible. These rarely led to discontinuation of afatinib treatment.(1)
Boehringer Ingelheim strives to make afatinib available to patients around the world. Further submissions worldwide are currently under preparation.
  1. Abstract no: LBA7500, LUX-Lung 3: A randomized, open-label, phase III study of afatinib versus pemetrexed and cisplatin as first-line treatment for patients with advanced adenocarcinoma of the lung harboring EGFR-activating mutations. Oral Presentation at 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) 2012.
  2. Scagliotti GV, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer.J Clin Oncol 2008;26(21):3543–51
  3. Abstract no: 1229PD. Sequist L. V. et al. LUX-Lung 3: Symptom and health-related quality of life results from a randomized phase III study in 1st-line advanced NSCLC patients harbouring EGFR mutations. ESMO 2012 Congress. Available at:

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