Afatinib News and Research

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Third-line treatment options remain elusive for advanced, EGFR wild-type NSCLC

Phase II study findings show only marginal positive effects of third-line treatment with afatinib for advanced non-small-cell lung cancer in patients with wild-type epidermal growth-factor receptor tumour status.

23 Jun 2014

Scientists discover important new biomarker that could improve HER2 targeted cancer treatments

Scientists from the School of Pharmacy & Pharmaceutical Sciences, Trinity College Dublin have made a significant discovery of a new biomarker which may help overcome resistance to newer and more targeted anti-cancer drugs, such as Herceptin, for HER2 positive cancers. These findings may also help the early identification of patients who will benefit more from these treatments.

11 Jun 2014

New data on Gilotrif and investigational compounds to be presented at 50th ASCO annual meeting

Boehringer Ingelheim today announced that new data will be presented from 7 abstracts for Gilotrif (afatinib) and investigational compounds, including nintedanib and BI 836845, from its oncology pipeline at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL, on May 30 – June 3, 2014.

31 May 2014

Lung cancer patients with Del19 mutation benefit most from afatinib

Afatinib has been approved in Germany since September 2013 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating EGF receptor mutations who have not been treated with an EGF receptor tyrosine-kinase inhibitor (EGFR TKI).

20 Feb 2014

Afatinib ‘first line’ for advanced mutation-positive lung cancer

Afatinib should be given as a first-line treatment for Asian patients with advanced, epidermal growth factor receptor mutation-positive, non-small-cell lung cancer, researchers recommend.

17 Feb 2014

Phase III trial shows afatinib offers clinical benefit to patients with EGFR mutation positive NSCLC

Afatinib has a novel mode of action and data has shown that it offers a clinical benefit to patients with a specific type of lung cancer, which we are further investigating in the extensive LUX-Lung clinical trial programme.

1 Aug 2013

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Companion test also approved to identify appropriate patients The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related death among men and women.

16 Jul 2013

FDA approves QIAGEN’s therascreen EGFR test as companion diagnostic for NSCLC patients

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received approval by the U.S. Food and Drug Administration (FDA) to market the therascreen EGFR test as a companion diagnostic to guide the use of Boehringer Ingelheim's new targeted therapy, GILOTRIF™ (afatinib), for treatment of metastatic NSCLC in patients whose tumors have certain EGFR gene mutations.

From QIAGEN Manchester Limited 15 Jul 2013

Study suggests lung cancer patients with HER2 mutations may benefit from anti-HER2 drugs

New results from a retrospective study conducted in Europe suggest that anti-HER2 treatments, like the widely used breast cancer agent trastuzumab (Herceptin), have anti-cancer effects in a small subset of patients with advanced non-small cell lung cancer (NSCLC) harboring specific HER2 protein mutations.

23 Apr 2013

Clarient adopts QIAGEN’s therascreen KRAS test to diagnose colorectal cancer

QIAGEN N.V. today announced that Clarient - a GE Healthcare Company and leading provider of cancer laboratory testing services in the United States - has adopted the use of the therascreen KRAS RGQ PCR Kit (therascreen KRAS test) as a companion diagnostic to guide the use of Erbitux (cetuximab) as a treatment in patients with metastatic colorectal cancer.

From QIAGEN Manchester Limited 30 Jan 2013

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA).

17 Jan 2013

Boehringer Ingelheim to commence volasertib plus LDAC Phase III study for AML

New positive Phase II results from an interim analysis of the randomised Phase I/II study involving the company's investigational haematology/oncology compound volasertib in newly diagnosed patients with acute myeloid leukemia (AML) considered ineligible for intensive remission induction therapy were presented at the 54th American Society of Hematology (ASH) annual meeting in Atlanta, USA.

10 Dec 2012

Boehringer Ingelheim files MAA with EMA for afatinib approval

Today, Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for approval of afatinib, the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support for this submission.

20 Sep 2012

Results from Boehringer Ingelheim’s LUX-Lung 3 Phase III trial on stage IIIB or IV NSCLC

Boehringer Ingelheim will present results from LUX-Lung 3, the company's pivotal Phase III clinical trial investigating afatinib in patients with stage IIIB or IV non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation (EGFR M+), at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 1-5, 2012.

17 May 2012

Results from Boehringer Ingelheim's afatinib Phase III lung cancer trial

Highly anticipated results from LUX-Lung 3, the pivotal Phase III lung cancer trial investigating Boehringer Ingelheim's front running oncology investigational compound, the ErbB Family Blocker afatinib, in patients with EGFR mutations, will be presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from 1 - 5 June 2012.

21 Apr 2012

Boehringer Ingelheim initiates two afatinib phase III trials in head and neck cancer

Boehringer Ingelheim announced today the initiation of two phase III clinical trials, LUX-Head & Neck 1 and LUX-Head & Neck 2. These trials evaluate afatinib in patients with metastatic and recurrent head and neck cancer, and in patients with locally advanced disease, respectively.

27 Jan 2012

NCCN ORP to evaluate clinical effectiveness of Boehringer Ingelheim's Afatinib in solid tumors

The National Comprehensive Cancer Network Oncology Research Program (ORP) has been awarded a $2 million grant from Boehringer Ingelheim Pharmaceuticals, Inc. to develop a program to scientifically evaluate and define the clinical effectiveness of Afatinib (BIBW 2992) in solid tumors, including breast, head and neck, and non-small cell lung (NSCL) cancers.

11 Nov 2011

Boehringer Ingelheim initiates two afatinib phase II studies in HER2-positive breast cancer

Boehringer Ingelheim today announced the initiation of two phase II studies, 1200.89 and LUX-Breast 2, evaluating afatinib in patients with metastatic breast cancer, who have an overexpression of the erbB2 (HER2) protein, so called HER2-positive patients. Afatinib is an irreversible ErbB Family Blocker, which binds to all erbB-family kinases including erbB2.

29 Aug 2011

Experimental vaccine shows promise for patients with newly diagnosed brain tumors

An experimental vaccine developed by researchers at Cedars-Sinai Medical Center's Maxine Dunitz Neurosurgical Institute targets overactive antigens in highly aggressive brain tumors and improves length of survival in newly diagnosed patients, according to new data that was presented in a poster session at the 47th Annual Meeting of the American Society of Clinical Oncology.

17 Jun 2011

Boehringer Ingelheim's new afatinib-cetuximab phase Ib data in NSCLC presented at ASCO 2011

Boehringer Ingelheim Pharmaceuticals, Inc. will present new phase Ib data at the 2011 American Society of Clinical Oncology annual meeting in Chicago that indicates combining its investigational therapy afatinib with cetuximab at the maximum tested dose controlled disease in all (n=22) treated epidermal growth factor receptor (EGFR)-mutation positive patients with non-small cell lung cancer who developed acquired resistance to treatment with a reversible EGFR tyrosine kinase inhibitor.

26 May 2011