Tuesday, August 25, 2015

FDA and EMA accept regulatory applications for Boehringer Ingelheim’s Giotrif® / Gilotrif® (afatinib) for treatment of advanced squamous cell carcinoma of the lung

INGELHEIM, Germany - Tuesday, August 25th 2015 [ME NewsWire]

    Regulatory submissions are based on positive data from LUX-Lung 8 study that showed a significant delay in progression of lung cancer (progression-free survival, primary endpoint) and a significant improvement in overall survival for Giotrif® (afatinib*) compared to Tarceva® (erlotinib)
    LUX-Lung 8 is a large, prospective Phase III head-to-head trial which compared two EGFR-directed treatments in patients with squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy
    Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition

(BUSINESS WIRE)-- Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition.

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim commented: “Working with the US and EU regulatory authorities marks the next stage in our journey to hopefully provide patients with a new, oral treatment for squamous cell carcinoma of the lung, a condition with an extremely poor prognosis and still limited treatment options. This is an encouraging prospect for Boehringer Ingelheim as we remain fully dedicated to improving and extending the lives of patients with different types of lung cancer.”

The submissions are based on data from the Phase III LUX-Lung 8 trial that compared Giotrif® / Gilotrif® (afatinib) to Tarceva® (erlotinib) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy. Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS, primary endpoint), reducing the risk of cancer progression by 19%, and superior overall survival (OS, key secondary endpoint), reducing the risk of death by 19% compared to erlotinib in this patient population.

In the LUX-Lung 8 trial, an improvement in quality of life and control of cancer symptoms was observed with afatinib versus erlotinib. More patients had improved overall health-related quality-of-life with afatinib than with erlotinib (36% vs 28%). Significantly more patients had an improvement in cough with afatinib than with erlotinib (43% vs 35%). Differences in the proportion of patients with improved dyspnoea (51% vs 44%) and pain (40% vs 39%) were not significant for afatinib versus erlotinib. Afatinib significantly delayed time to deterioration of dyspnoea compared with erlotinib. Time to deterioration of both pain and cough was similar for afatinib versus erlotinib.

The rate of severe adverse events was similar between the two treatment arms with differences observed in the incidence of certain side effects. A higher incidence of severe diarrhea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3 diarrhea: 10% vs 2%; grade 3 stomatitis: 4% vs 0%), while a higher incidence of severe rash/acne was reported with erlotinib compared to afatinib (grade 3 rash/acne: 10% vs 6%).

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85% of lung cancer cases. Squamous cell lung cancer develops in the cells lining the airways and represents approximately 30% of NSCLC cases. SCC of the lung is associated with a poor prognosis and limited survival. The median overall survival after diagnosis of advanced SCC is around one year.

Afatinib, an oral, once daily EGFR-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive NSCLC (under brand names: Giotrif® / Gilotrif®). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUX-Lung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.

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This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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Email: press@boehringer-ingelheim.com

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