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MEDIA ALERT New Data Show Giotrif® (Afatinib) Provided More than One Year Additional Survival for Lung Cancer Patients with the Most Common Type of EGFR Mutation (del19) Compared to Chemotherapy

"Boehringer Ingelheim today announced results of the pre-specified individual, as well as the exploratory combined, analyses of two Phase III trials (LUX-Lung 3 and LUX-Lung 6). These data, to be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), demonstrated for the first time that patients with NSCLC with the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletions; del19) lived more than one year longer if treated with first-line afatinib compared to chemotherapy."


Editor's note: This article discusses the results of a clinical trial that tested a targeted drug called afatinib (aka Giotrif, or Gilotrif)  on volunteer patients with non-small cell lung cancer (NSCLC). The trial found that patients whose tumors had a particular mutation called del19 in the EGFR gene lived more than one year longer if treated with afatinib than if treated with chemotherapy. EGFR mutations and other mutations are detected via molecular testing, and can be used by oncologists to help develop personalized lung cancer treatment plans.

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Boehringer Ingelheim  |  Jun 2, 2014

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Gilotrif Shows Effectiveness in Various Patient Populations with EGFR-Mutant Lung Cancer

Afatinib (Gilotrif) is a new lung cancer drug for people with non-small cell lung cancer (NSCLC) who have mutations in the EGFR gene. The LUX-Lung 3 clinical trial demonstrated that Gilotrif is superior to chemotherapy as first-line treatment in a global population of patients with EGFR-mutant NSCLC. The LUX-Lung 6 trial confirmed these findings specifically in an Asian population; Asia has a three times higher rate of EGFR-mutant NSCLC than Western countries. More recent evidence indicates that Gilotrif is as effective in patients with rare EGFR mutations as it is in those with common mutations. Finally, Gilotrif recently showed effectiveness in NSCLC patients whose cancer had spread to the brain.

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Moneylife | Oct 28, 2013

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Gilotrif to Be Commercially Available in the U.S. Soon

Afatinib (Gilotrif), a new drug for the treatment of some lung cancers, will become commercially available in the U.S. beginning the week of September 2. Gilotrif is approved as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have certain mutations in the EGFR gene. A companion diagnostic, the therascreen EGFR RGQ PCR Kit, can detect these specific EGFR mutations, so-called exon 19 deletions or exon 21 (L858R) substitutions. The makers of the drug will offer a patient support program to provide financial and other support to help patients who might otherwise not have access to Gilotrif.

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Yahoo! Finance | Aug 22, 2013

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Afatinib May Be Candidate for First-Line Treatment in Certain Lung Cancers

Results from the LUX-Lung 3 clinical trial show that afatinib appears to be well tolerated and more effective than chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Afatinib produced higher response rates and longer periods without cancer progression than cisplatin (Platinol) plus pemetrexed (Alimta), suggesting that it could be considered as a first-line therapy in advanced EGFR-mutant NSCLC. Afatinib, which is under priority review for approval by the FDA, may be effective in patients resistant to other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa). However, no trials so far have directly compared afatinib with Tarceva or Iressa.

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Medscape | Jul 9, 2013

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Novel Drugs Show Promise in Non-Small Cell Lung Cancer

Novel Drugs Show Promise in Non-Small Cell Lung Cancer | Lung Cancer Dispatch | Scoop.it

Medical experts at the 2012 Chemotherapy Foundation Symposium presented data on the growing number of targeted treatments for non-small cell lung cancer (NSCLC) with so-called driver mutations—specific genetic mutations that drive tumor growth. Among the drugs showing promise in adenocarcinoma are ridaforolimus for KRAS-mutant tumors, ganetespib for ALK- or KRAS-mutant tumors, and afatinib for EGFR-mutant tumors. For squamous cell carcinoma (SCC), new potential treatments include AZD4547 and BGJ398 (FGFR1-mutant), dasatinib and nilotinib (DDR2 mutant), Tarceva and Iressa (EGFRvIII-mutant), and Yervoy and Cadi-05 (all SCC), while anti–PD-1 antibodies such as BMS-936558 may be effective for both adenocarcinoma and SCC.

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OncLive | Jan 14, 2013

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New Lung Cancer Drug Afatinib Accepted for FDA Review

New Lung Cancer Drug Afatinib Accepted for FDA Review | Lung Cancer Dispatch | Scoop.it

The FDA will consider afatinib, a novel lung cancer drug, for treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors carry a mutation in the epidermal growth factor receptor (EGFR) gene. Afatinib belongs to a class of drugs called tyrosine kinase inhibitors (TKIs) and may be useful both for patients who have never received TKI treatment and those who have previously been treated with other TKIs. In combination with cetuximab (Erbitux), afatinib may be effective in patients who have become resistant to treatment with erlotinib (Tarceva).

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OncLive | Jan 15, 2013

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NICE Draft Guidance Recommends Boehringer Ingelheim’s Giotrif

NICE Draft Guidance Recommends Boehringer Ingelheim’s Giotrif | Lung Cancer Dispatch | Scoop.it

"UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new draft guidance recommending German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) as an option for treating locally-advanced or metastatic non-small-cell lung cancer (NSCLC) in people whose tumors test positive for the EGFR-TK mutation and have not received a EGFR-TK inhibitor."


Editor's Note: In the US, this drug is called Gilotrif. It is meant for patients whose tumors have a mutation in the EGFR gene, as detected by molecular testing. Learn more about molecular testing to guide treatment decisions.

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The Pharma Letter  |  Mar 17, 2014

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Cancer Researcher: No Need for Further EGFR Inhibitor Versus Chemotherapy Trials

No more trials comparing EGFR inhibitors to chemotherapy in patients with non-small cell lung cancer (NSCLC) should be conducted, argues an editorial by cancer researcher Corey Langer. Eight separate trials have found that EGFR inhibitors like erlotinib (Tarceva), gefitinib (Iressa), and afatinib (Gilotrif) produce better results than chemotherapy in NSCLC patients who have mutations in the EGFR gene. No further confirmation is needed, Langer contends. Instead, research should focus on ways to overcome the drug resistance that many patients eventually develop to EGFR inhibitors, meaningfully extending overall survival in NSCLC, and directly comparing the relative effectiveness and safety of Tarceva, Iressa, and Gilotrif.

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Medscape | Sep 3, 2013

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FDA Approves Afatinib/Gilotrif for Lung Cancer Treatment

Based on the positive results of a recent clinical trial, the FDA approved afatinib for first-line treatment of patients with late-stage, non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. The drug, which will be marketed under the name Gilotrif, is specifically intended for patients with two particular EGFR mutations: exon 19 deletion and exon 21 L858R substitution. The FDA also approved the therascreen EGFR RGQ PCR Kit, a companion diagnostic used to test for EGFR mutations. Afatinib differs from other EGFR inhibitors like erlotinib (Tarceva) and gefitinib (Iressa) in that it irreversibly destroys the EGFR protein, instead of just reversibly blocking it, and also inhibits several other related proteins.

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Food and Drug Administration (FDA) | July 12, 2013

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Scientists Discuss EGFR Inhibition and Its Limitations in NSCLC

A review of recent research discusses EGFR inhibition in the treatment of non-small cell lung cancer (NSCLC). Blocking EGFR using drugs called EGFR-tyrosine kinase inhibitors (TKIs) is an effective treatment for advanced NSCLC in patients with mutations in the EGFR gene. However, chemotherapy remains the standard of care for advanced NSCLC without EGFR mutations. Unfortunately, patients commonly develop drug resistance to TKIs like erlotinib (Tarceva) or gefitinib (Iressa). Newer TKIs like afatinib, which target multiple proteins and irreversibly inhibit them, are being explored in clinical trials and may be effective in patients who have become resistant to first-generation TKIs.

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Journal of Thoracic Oncology | Jan 29, 2013

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FDA Grants Expedited Review to Two Lung Cancer Drugs

FDA Grants Expedited Review to Two Lung Cancer Drugs | Lung Cancer Dispatch | Scoop.it

Two lung cancer drugs, erlotinib (Tarceva) and afatinib, have been granted Priority Review status by the FDA. Priority Review is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and means that the time it takes the FDA to review a new drug application is reduced. Clinical trials found that both drugs produced longer progression-free survival in patients with advanced, EGFR mutation-positive non-small cell lung cancer (NSCLC) than currently approved therapies.

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PMLiVE | Jan 17, 2013

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