Drugs / BIBW 2992 MA2
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | GILOTRIF | — | 2015-11-09 – 2022-04-07 | fda.gov ↗ |
| Approved | US (FDA) | GILOTRIF | — | 2013-07-12 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02451553 | Nov 2015 → Apr 2022 | bile duct carcinoma, exocrine pancreatic carcinoma, high grade malignant neoplasm | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT02171689 | Jul → Aug 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02541903 | Oct 2015 → Jan 2019 | squamous cell carcinoma of penis | University of Alabama at Birmingham | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02747953 | Jul 2011 → Dec 2014 | non-small cell lung carcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT02171715 Comparator | Jan → Apr 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2020-10-13 | Boehringer Ingelheim | Results IASLC NACLC 2020: Boehringer Ingelheim presents new data for Gilotrif® in metastatic, squamous cell carcinoma of the lung, and in EGFR mutation-positive NSCLC prnewswire.com ↗ |
| 2020-09-02 | Boehringer Ingelheim | Results Final analysis of the observational GioTag study: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small cell lung cancer prnewswire.com ↗
The final GioTag results support the results of our previous analyses, that sequential afatinib and osimertinib treatment could be a feasible and effective therapeutic strategy in a broad, real-world population of patients with EGFR M+ NSCLC who acquire T790M. |
| 2020-08-10 | Boehringer Ingelheim | Results Additional analysis of real-world data confirms sequential Gilotrif® followed by osimertinib provided a median overall survival of nearly four years in U.S.-treated patients with EGFR mutation-positive NSCLC prnewswire.com ↗
These real-world data provide further insight into the overall survival associated with afatinib and subsequent osimertinib treatment and reinforce that previous findings may have application in the U.S. treatment setting for patients with T790M acquired resistance. |
| 2019-08-05 | Boehringer Ingelheim | Results Updated real-world data show Gilotrif® followed by osimertinib provided a median overall survival of up to almost four years in patients with EGFR Del19 and T790M mutation-positive NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumors. |
| 2018-10-22 | Boehringer Ingelheim | Results Real-world study shows sequencing of Gilotrif® followed by osimertinib delivered a combined median time on treatment of 27.6 months in patients with EGFR mutation-positive NSCLC prnewswire.com ↗
According to the study, the median time on treatment for sequential afatinib and osimertinib was 27.6 months. |
| 2018-01-16 | Boehringer Ingelheim | Regulatory FDA approves new indication for Gilotrif® in EGFR mutation-positive NSCLC prnewswire.com ↗
The FDA granted Priority Review status to Gilotrif in evaluating this application. |
| 2017-10-10 | Boehringer Ingelheim | Regulatory FDA grants Priority Review to Gilotrif® for uncommon EGFR mutations in advanced NSCLC prnewswire.com ↗
Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). |
| 2016-10-09 | Boehringer Ingelheim | Results Overall survival data from LUX-Lung 7 head-to-head trial of Gilotrif® (afatinib) versus Iressa® (gefitinib) presented at ESMO prnewswire.com ↗
The median survival of patients treated with afatinib was 27.9 months compared to 24.5 months for those receiving gefitinib, without reaching significance. |
| 2016-09-08 | Boehringer Ingelheim | Results New analysis showed dose adjustment of Gilotrif® (afatinib) improved tolerability without an apparent impact on efficacy in patients with EGFR mutation-positive non-small cell lung cancer prnewswire.com ↗
Results from a new post-hoc analysis of two large Phase III trials (LUX-Lung 3 and LUX-Lung 6) assessing the impact of dose adjustments for Gilotrif ® (afatinib) in patients with advanced non-small cell lung cancer (NSCLC) were published today in Annals of Oncology. |
| 2016-04-15 | Boehringer Ingelheim | Regulatory FDA approves Gilotrif® (afatinib) as new oral treatment option for patients with squamous cell carcinoma of the lung prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. |
| 2016-04-13 | Boehringer Ingelheim | Results Head-to-head study demonstrating Gilotrif® (afatinib) significantly improved clinical outcomes compared to Iressa® (gefitinib) in EGFR mutation-positive advanced non-small cell lung cancer published in The Lancet Oncology prnewswire.com ↗
Results from the LUX-Lung 7 trial showed that afatinib significantly reduced the risk of lung cancer progression by 27% versus gefitinib. |
| 2016-01-27 | Boehringer Ingelheim | Results Boehringer Ingelheim's Gilotrif® (afatinib) demonstrated superiority to Iressa® (gefitinib) in reducing the risk of disease progression and treatment failure in first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer prnewswire.com ↗
Boehringer Ingelheim announced today the results of the LUX-Lung 7 trial. |
| 2015-08-25 | Boehringer Ingelheim | Regulatory FDA and EMA accept regulatory applications for Boehringer Ingelheim's Gilotrif® (afatinib) for treatment of advanced squamous cell carcinoma of the lung prnewswire.com ↗
Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. |
| 2015-05-31 | Boehringer Ingelheim | Results ASCO 2015: Superior overall survival for afatinib compared to erlotinib demonstrated in head-to-head trial in patients with previously treated advanced squamous cell carcinoma of the lung prnewswire.com ↗
Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. |
| 2015-05-14 | Boehringer Ingelheim | Results Boehringer Ingelheim showcases expanding presence in lung cancer at ASCO with new data including presentation of Gilotrif® (afatinib) overall survival results for squamous cell carcinoma of the lung prnewswire.com ↗
The study met its primary endpoint of progression-free survival, as well as its key secondary endpoint of overall survival (OS). |
| 2015-01-12 | Boehringer Ingelheim | Results The Lancet Oncology publishes phase III data showing Gilotrif® (afatinib) extends overall survival in lung cancer patients whose tumors have the most common EGFR mutation compared with chemotherapy prnewswire.com ↗
Boehringer Ingelheim today announced overall survival (OS) results were published in The Lancet Oncology from two independent Phase III clinical trials ( LUX-Lung 3 and LUX-Lung 6 ) in epidermal growth factor receptor (EGFR) mutation-positive patients with metastatic non-small cell lung cancer (NSCLC). |
| 2014-09-29 | Boehringer Ingelheim | Results Head-to-head Phase III trial demonstrates superior progression-free survival of afatinib compared to erlotinib in patients with advanced squamous cell carcinoma of the lung prnewswire.com ↗
Phase III data from Boehringer Ingelheim's LUX-Lung 8 trial, the first study to evaluate the superiority of afatinib versus erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung, demonstrated superior improvement in progression-free survival (PFS) with afatinib compared to erlotinib. |
| 2014-05-30 | Boehringer Ingelheim | Results ASCO 2014: Boehringer Ingelheim to present its latest oncology research including new data for Gilotrif® (afatinib) in advanced lung cancer patients prnewswire.com ↗
An early interim overall survival analysis of a randomized Phase 3 trial in HER2 positive metastatic breast cancer showed an increased mortality in patients receiving GILOTRIF in combination with vinorelbine compared to trastuzumab and vinorelbine. |
| 2014-05-14 | Boehringer Ingelheim | Results New data for Boehringer Ingelheim's Gilotrif® (afatinib) shows a significant improvement in overall survival in lung cancer patients whose tumors have the most common EGFR mutation prnewswire.com ↗
Patients with advanced non-small cell lung cancer (NSCLC) whose tumors have the most common epidermal growth factor receptor (EGFR) mutation (exon 19 deletion) lived longer if treated with first-line afatinib compared to chemotherapy. |
| 2013-07-12 | Boehringer Ingelheim | Regulatory FDA approves GILOTRIF™ (afatinib) as first-line treatment for metastatic non-small cell lung cancer with common EGFR mutations prnewswire.com ↗ |
| 2013-01-15 | Boehringer Ingelheim | Regulatory U.S. FDA Grants Priority Review to Boehringer Ingelheim's Afatinib NDA for EGFR Mutation-Positive Advanced NSCLC prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) 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). |
| 2011-05-25 | Boehringer Ingelheim | Results Boehringer Ingelheim to present new data at ASCO annual meeting regarding its investigational compound afatinib in EGFR-mutation positive patients with advanced NSCLC prnewswire.com ↗
Researchers observed a tumor size reduction of up to 76 percent over a treatment period of up to five months.(1) |
| 2010-12-09 | Boehringer Ingelheim | Results New Subgroup Analysis of LUX-Lung 1 Trial Suggests Afatinib Increases Progression-Free Survival in Advanced Lung Cancer Patients More Likely to Have EGFR Mutations prnewswire.com ↗
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. |
| 2010-10-11 | Boehringer Ingelheim | Results New Afatinib (BIBW 2992) Data in Non-Small Cell Lung Cancer Patients Presented at the 2010 ESMO Congress prnewswire.com ↗ |
| 2010-05-20 | Boehringer Ingelheim | Results Boehringer Ingelheim to Present New Data Regarding Its Investigational Compound BIBW 2992 in Head and Neck Cancer and Non-Small Cell Lung Cancer prnewswire.com ↗
Twenty-two percent of the 34 patients receiving BIBW 2992 experienced reduction in tumor size (measured as partial response), compared to 13 percent of the 40 patients receiving cetuximab. |
All press releases naming this drug 27 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BIBW 2992 MA2 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02171715 ↗ |
| Known as | Afatinib Dimaleate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02451553 ↗ |
| Known as | BIBW 2992 | “Relative Bioavailability of a Single Dose 20 mg BIBW 2992 Administered as Tablet (Final Formulation) Compared to BIBW 2992 Drinking Solution and BIBW 2992 Tablet (Trial...” NCT02171715 ↗ |
| Known as | Gilotrif | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02747953 ↗ |
| Action | Inhibit | “blocking some of the enzymes needed for cell growth” NCT02451553 ↗ |
| Route | Oral | “after a single oral dose of \[14C\]-radiolabelled BIBW 2992 MA2” NCT02171689 ↗ |
| Target | EGFR | “Irreversible EGFR/HER2 Tyrosine Kinase Inhibitor” NCT02451553 ↗ |