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FDA approves expanded indication for Gilotrif

US body gives Boehringer Ingelheim’s oral lung cancer treatment the nod

Boehringer Ingelheim has won US licensing for the expanded use of its EGFR-directed non-small cell lung cancer (NSCLC) drug Gilotrif.

The authorisation by the US regulator means that Gilotrif (afatinib) can now be provided as a second-line treatment for patients with squamous cell carcinoma (SqCC) of the lung whose disease has progressed despite chemotherapy.

It is the first oral treatment for advanced SqCC of the lung to be approved in the US and follows its recent marketing authorisation for this subset of patients in Europe.

“This approval is further evidence of Boehringer Ingelheim's strong commitment to bringing new treatment options to the lung cancer community,” commented Sabine Luik, senior vice president of medicine and regulatory affairs.

First licensed in 2013, Gilotrif marked Boehringer Ingelheim's entry into the oncology market and the drug has since been made available in over 60 countries for the treatment of patients with EGFR-positive NSCLC.

Gilotrif's expanded approval comes on the back of the head-to-head LUX Lung 8 study, which is part of the LUX Lung programme and is the largest collection of clinical trials of EGFR tyrosine kinase inhibitors.

It showed Gilotrif achieved its primary objective of significantly improving progression-free survival when compared against Roche/Astellas' Tarceva (erlotinib).

Overall survival was improved by 19% with the once-daily oral form allowing patients greater control over their cancer symptoms as well as a better quality of life.

SqCC of the lung is the second largest sub-type of NSCLC, accounting for 20-30% of all cases. It is associated with a poor prognosis and limited survival, with the median overall survival after diagnosis of advanced SqCC being around one year.

Gilotrif joins several EGFR-targeting therapies already on the market in the US and Europe, including AstraZeneca's Tagrisso (omisertinib), Bristol-Myers Squibb's Opdivo (nivolumab) and Roche/Astellas' Tarveca (erlotinib).

Article by
Rebecca Clifford

18th April 2016

From: Regulatory



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