News Headline: BI personalized NSCLC drug approved in Europe
Outlet Full Name: Pharma Times
Author Name: Kevin Grogan
Boehringer Ingelheim has received a boost after getting the green light for its targeted lung cancer drug Giotrif.
Specifically, the European Commission has granted marketing authorisation for Giotrif (afatinib) for the treatment of patients with metastatic non-small cell lung cancer whose tumours express specific types of epidermal growth factor receptor (EGFR) gene mutations. The prevalence of tumours harbouring EGFR mutations is between 10-15% in Caucasian and 40% in Asian NSCLC patients.
The drug, which was approved in the USA in July (as Gilotrif), has been given the thumbs-up principally on the basis of data from the Phase III LUX-Lung 3 trial which have shown that patients taking afatinib as a first-line treatment lived for 11.1 months without their tumour growing again versus 6.9 months for those treated with pemetrexed/cisplatin. In addition, a subgroup analysis has shown that NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib experienced median progression-free survival of 13.6 months versus PFS of 6.9 months) for those in the comparator arm.
Boehringer said that early mutation testing for EGFR status is “a crucial step in the treatment-decision pathway, to give patients the opportunity to receive the appropriate personalised therapy from the start”. A companion diagnostic has been made by Qiagen.
Klaus Dugi, head of medicine at Boehringer, said “we hope this will be the first of many registrations for drugs from our in-house oncology research programme”, adding that “this is a significant step towards meeting the substantial unmet need in lung cancer treatment.”
China facility expansion
Meantime, Boehringer has inaugurated the expansion of its plant at the Zhangjiang High-Tech Park in Shanghai. The move, which has cost 70 million euros, will see the number of employees rise significantly to 350.
The company says that the project consists of a packaging centre with space for high-tech packaging lines, new quality control labs, and automated warehouse and logistics “to ensure the reliable and high quality supply and also to launch new products”. Wolfgang Baiker, board member responsible for biopharmaceuticals and operations, said “we will invest further into the site in 2014 to set up a development lab for biopharmaceuticals”.