Giotrif® (afatinib) approved in Europe as new oral treatment option for patients with squamous cell carcinoma of the lung
• Approval provides a new oral treatment option for patients with the second largest sub-type of non-small cell lung cancer (NSCLC), representing approximately 20-30% of NSCLC cases.1,2• Approval of Giotrif® is based on results of the LUX-Lung 8 study, which showed significantly improved overall survival and progression-free survival compared to Tarceva® (erlotinib) in patients with squamous cell carcinoma of the lung3• Afatinib is already approved in more than 60 countries for the treatment of patients with EGFR mutation-positive NSCLC* (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - April 6, 2016 Category: Research Source Type: news
Cranial Irradiation in EGFR-Mutant NSCLC Brain MetastasesCranial Irradiation in EGFR-Mutant NSCLC Brain Metastases
Is erlotinib plus radiotherapy superior to either therapy alone for brain metastases associated with NSCLC? Translational Lung Cancer Research (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 4, 2016 Category: Consumer Health News Tags: Hematology-Oncology Journal Article Source Type: news
Drug combination reduces polyps for patients with high risk for colorectal cancer
In a recent study, researchers randomly assigned 92 patients with familial adenomatous polyposis to the drugs sulindac twice daily and erlotinib daily (n = 46) or placebo (n = 46) for 6 months. The outcome of the study showed very positive results for those with a high risk of colorectal cancer (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - March 22, 2016 Category: Science Source Type: news
Sulindac plus erlotinib reduces duodenal polyp burden
Combination therapy with sulindac and erlotinib reduced the burden of duodenal polyps in a preliminary study involving 92 patients with familial adenomatous polyposis (FAP), which was reported online... (Source: Family Practice News)
Source: Family Practice News - March 22, 2016 Category: Primary Care Source Type: news
Drug combination reduces polyps for patients with high risk for colorectal cancer
(The JAMA Network Journals) In a study appearing in the March 22/29 issue of JAMA, Deborah W. Neklason, Ph.D., N. Jewel Samadder, M.D., M.S., of the Huntsman Cancer Institute, University of Utah, Salt Lake City, and colleagues randomly assigned 92 patients with familial adenomatous polyposis to the drugs sulindac twice daily and erlotinib daily (n = 46) or placebo (n = 46) for 6 months. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - March 22, 2016 Category: Cancer & Oncology Source Type: news
Erlotinib cost-effective option in EGFR-mutated NSCLC
(Source: PharmacoEconomics and Outcomes News)
Source: PharmacoEconomics and Outcomes News - March 1, 2016 Category: Drugs & Pharmacology Source Type: news
Could a Lung Cancer Drug Work Better With Coke?
Study finds cola boosts effectiveness of Tarceva for patients who are also taking a heartburn medicine (Source: Cancercompass News: Other Cancer)
Source: Cancercompass News: Other Cancer - February 14, 2016 Category: Cancer & Oncology Source Type: news
Could a Lung Cancer Drug Work Better With Coke?
Study finds cola boosts effectiveness of Tarceva for patients who are also taking a heartburn medicine (Source: WebMD Health)
Source: WebMD Health - February 12, 2016 Category: Consumer Health News Source Type: news
Could a Lung Cancer Drug Work Better With Coke?
Study finds cola boosts effectiveness of Tarceva for patients who are also taking a heartburn medicine (Source: U.S. News - Health)
Source: U.S. News - Health - February 12, 2016 Category: Consumer Health News Source Type: news
Could a Lung Cancer Drug Work Better With Coke?
Study finds cola boosts effectiveness of Tarceva for patients who are also taking a heartburn medicine (Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - February 12, 2016 Category: Cancer & Oncology Authors: webmaster at doctorslounge.com Tags: Gastroenterology, Nursing, Oncology, News, Source Type: news
Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015:
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 69
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Summary of PMA Supplements Under Review
Total Under Review: 583
Total Active: 433
Total On Hold: 150
Summary of All PMA Submissions
Originals: 4
Supplements: 75
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 193.4
FDA Time: 1...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Delhi HC upholds Roche's patent claims on Tarceva against Cipla
In a statement to ET, Roche said it welcomed the decision of the court, which has upheld the patent covering erlotinib hydrochloride. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 27, 2015 Category: Pharmaceuticals Source Type: news
Erlotinib Fails at Chemoprevention of Oral CancerErlotinib Fails at Chemoprevention of Oral Cancer
In the first precision-based chemoprevention study, erlotinib failed to significantly prevent the development of oral cancer in patients with oral premalignant lesions. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 5, 2015 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
First Precision Medicine Chemoprevention Trial DisappointsFirst Precision Medicine Chemoprevention Trial Disappoints
In the first precision-based chemoprevention study, erlotinib failed to significantly prevent the development of oral cancer in patients with oral premalignant lesions. Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - November 5, 2015 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
