Friday, November 28, 2014

Vargatef® (nintedanib*) approved in the EU for lung cancer patients with advanced adenocarcinoma after first-line chemotherapy

INGELHEIM, Germany - Thursday, November 27th 2014 [ME NewsWire]

• Nintedanib*, when added to docetaxel, demonstrated over one year (12.6 months) median overall survival for advanced lung cancer patients with adenocarcinoma after first-line chemotherapy (vs. 10.3 months for patients receiving docetaxel alone)1

• The approval of nintedanib* in the European Union (EU) is primarily based on the positive results of the LUME-Lung 1 study of over 1,300 patients in 27 countries1

• In oncology, nintedanib* will be marketed in the EU under the brand name Vargatef®

(BUSINESS WIRE) - For media outside UK, US and Canada only

Today Boehringer Ingelheim announced that the European Commission has granted EU marketing authorisation for Vargatef® (nintedanib*), valid for the 28 countries within the EU. Vargatef® in combination with docetaxel is indicated for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy.

“The approval of nintedanib offers a much needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting,” commented PD. Dr Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany and lead investigator of the LUME-Lung 1 trial. “The clinical data has shown that patients receiving nintedanib plus docetaxel experienced over one year overall survival with no further compromise to their quality of life, compared to docetaxel alone.”

Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage.2 Most patients will experience disease progression during or after first-line chemotherapy and there is a significant unmet need for new, effective second-line treatments.3

“We are delighted by the European Commission’s decision to approve Vargatef® in the EU and feel extremely proud that our long standing commitment to oncology research and development has brought a new option to lung cancer patients with this specific type of disease,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “The approval of Vargatef® expands our oncology portfolio, following last year’s approval of GIOTRIF® (afatinib) for another specific type of lung cancer. In the idiopathic pulmonary fibrosis indication, nintedanib has recently been approved by the U.S. FDA.”

The approval of nintedanib*, a triple angiokinase inhibitor, is based on the outcomes of the LUME-Lung 1 clinical trial which enrolled 1,314 patients with NSCLC, after first-line chemotherapy.1 Data from the study, published in Lancet Oncology (Feb 2014), demonstrated that compared to docetaxel alone, nintedanib* when added to docetaxel significantly extended median overall survival from 10.3 to 12.6 months (p=0.0359; HR: 0.83) for patients with adenocarcinoma, with a quarter of patients surviving for two years or more (survival at 24 months – nintedanib* plus docetaxel, 25.7% of patients vs. placebo plus docetaxel, 19.1% of patients, p=0.0359; HR: 0.83).1

Nintedanib* demonstrated a manageable adverse event profile without further compromising patients’ overall health-related quality of life. Adding nintedanib* to docetaxel did not significantly increase discontinuation rates, compared to docetaxel alone.1

Nintedanib* is an oral, twice-daily treatment and is the second approved compound in the Boehringer Ingelheim oncology portfolio. GIOTRIF® (afatinib‡) was the first oncology drug from the portfolio to be approved to treat non-small cell lung cancer patients with distinct types of EGFR-mutation positive NSCLC.

*Nintedanib is approved in the EU under the brand name Vargatef® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.

‡Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the US under the brand name GILOTRIF® for use in patients with distinct types of EGFR mutation-positive NSCLC. Registration conditions differ internationally, please refer to locally approved prescribing information. Afatinib is under regulatory review by health authorities in other countries worldwide. Afatinib is not approved in other indications

-- ENDS –

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