Afatinib News and Research

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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

Broad opportunities for covalent drugs

Avila Therapeutics, Inc., a biotechnology company developing novel targeted covalent drugs, today announced the publication of a scientific review article in Nature Reviews Drug Discovery titled "The Resurgence of Covalent Drugs".

1 Apr 2011

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Boehringer Ingelheim Pharmaceuticals, Inc. announced that new data from a subgroup analysis of the phase IIb/III LUX-Lung 1 trial show that afatinib (BIBW 2992) reached a four-fold extension (4.4 months vs. 1.0 month for placebo) in progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients most likely to have an epidermal growth factor receptor (EGFR) mutation. The updated LUX-Lung 1 data will be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

13 Dec 2010

Afatinib benefits lung cancer patients whose cancer progressed after treatment with EGFR inhibitors

Lung cancer patients who have already been treated with the EGFR inhibitors erlotinib or gefitinib seem to gain further benefits in terms of progression-free survival and tumor shrinkage when treated with the new drug afatinib, the results of a Phase IIb/III trial show.

11 Oct 2010

Boehringer Ingelheim announces results from afatinib clinical trials at 35th ESMO

Boehringer Ingelheim Pharmaceuticals, Inc. announced today results from two clinical trials for its investigational cancer compound afatinib* (BIBW 2992) presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

11 Oct 2010

Boehringer Ingelheim commences afatinib Phase III clinical trial in advanced breast cancer

Boehringer Ingelheim today announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal growth factor receptor (EGFR/HER1) and the human epidermal receptor HER2, which are involved in tumour growth and spread.

18 Sep 2010

Afatinib News and Research

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

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

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

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

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

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

Boehringer Ingelheim files MAA with EMA for afatinib approval

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

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

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

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

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

Experimental vaccine shows promise for patients with newly diagnosed brain tumors

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

Broad opportunities for covalent drugs

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Afatinib benefits lung cancer patients whose cancer progressed after treatment with EGFR inhibitors

Boehringer Ingelheim announces results from afatinib clinical trials at 35th ESMO

Boehringer Ingelheim commences afatinib Phase III clinical trial in advanced breast cancer

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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