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Jul 16, 2013, 04.43 PM IST | Source: Business Wire India

USFDA approves Gilotrif (afatinib)

Boehringer Ingelheim announced that the US Food and Drug Administration has approved afatinib tablets under the US brand name GILOTRIFTM for oral use.

USFDA approves Gilotrif (afatinib)

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved afatinib tablets under the US brand name GILOTRIFTM for oral use, as a new first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.2

Lung cancer is the biggest cancer killer in the world with incidence rates higher in men than in women, it accounts for 1.6 million new cancer cases annually.3 However, lung cancer isn’t just one disease; research has shown there are many different types requiring specific treatment approaches. One distinct subtype of lung cancer is defined by mutations in EGFR (a member of the ErbB Family of receptors). These are patients that in clinical trials have been shown to benefit most from afatinib treatment.

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"We are delighted to announce the first approval of afatinib, offering a new personalised treatment approach for patients with EGFR mutation positive NSCLC," said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "It marks the first of what we hope will be many products to emerge from our oncology research and development programme, and underscores our continued commitment to translating innovative science into new treatment options for patients."

In the US, afatinib received orphan drug status and was assessed under the FDA's priority review programme, which provides an expedited review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Boehringer Ingelheim strives to make afatinib available to patients around the world. Afatinib has been submitted to the EMA and regulatory authorities in Asia and other countries for treatment of EGFR mutation positive locally advanced and metastatic NSCLC.

The approval of afatinib in the US is based on data from the pivotal LUX-Lung 3 trial, comparing afatinib to chemotherapy with pemetrexed/cisplatin. Data from LUX-Lung 3 has shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. In addition, NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumour 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 taking afatinib also experienced an improvement in lung cancer symptoms and a better quality of life compared to those receiving standard chemotherapy treatment.

The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). One percent of patients in the afatinib arm discontinued due to drug-related diarrhoea.1

* In the US., afatinib is approved under the US brand name GILOTRIF™. Afatinib is under regulatory review by EMA and health authorities in Asia and other countries.

Notes to Editors

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/15_july_2013_oncology.html

References

1 Sequist L, Yang J, Yamamoto N, et al. Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With Epidermal Growth Factor Receptor Mutations. J Clin Oncol 2013;DOI: 10.1200/JCO.2012.44.2806

2 U.S. GILOTRIF™ Prescribing Information

3 Ferlay J, Shin HR, Bray F, et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-917.

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