INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
issued a positive opinion for an update to the European label for Giotrif®
(afatinib*), strengthening and broadening the efficacy profile based on
additional Phase III data. About Rheumatrex (Methotrexate) with free prescription The CHMP recommendation includes data from
the LUX-Lung 3 and 6 trials which showed patients whose tumours have the
most common EGFR mutation (deletion in exon 19; del19) lived more than
one year longer when treated with first-line Giotrif®
compared to standard chemotherapy (overall survival; OS = secondary
endpoint, progression-free survival; PFS = primary endpoint).
Dr. Elocon (Mometasone) without prescription Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer
Ingelheim commented, “This update to the European label reinforces the
importance of Giotrif® as a targeted treatment for patients
with EGFR mutation-positive NSCLC, especially for those whose tumours
harbor the most common mutation, del19. About Macrobid (nitrofurantoin monohydrate) with no Rx Giotrif® is the first
and only targeted agent to date to have shown an overall survival
benefit for these patients in the first-line setting.”
Following CHMP positive opinion, the European prescribing information
will now be updated to include additional data from LUX-Lung 3 and
LUX-Lung 6. Eldepryl with no Rx Both studies met the primary endpoint of PFS for patients
whose tumours have common EGFR mutations receiving first-line Giotrif®. Retin-A (Tretinoin) with free prescription
In addition to new OS data, updated PFS data from the two trials will
also be reflected in the updated European label, as will the significant
improvements in lung cancer-related symptoms (cough, shortness of
breath, pain) and quality of life observed with Giotrif®
compared to chemotherapy.
Adverse events for Giotrif® in the LUX-Lung 3 and 6 trials
were as expected with EGFR inhibition and were predictable, manageable
and reversible. Buy Appetite Suppressants online Diarrhoea and rash/acne were the most
frequently reported side effects with Giotrif® therapy.
NSCLC is the most common form of lung cancer comprising over 85% of lung
cancer cases. http://cardiobloodreview.wordpress.com EGFR mutation-positive NSCLC is a subtype of
lung cancer. EGFR mutations are found in 10-15% of Caucasian and 40% of
Asian patients with NSCLC. There are different types of EGFR mutations;
the most common, which account for 90% of all EGFR mutations being del19
(approx. 50%) and L858R (approx. 40%). Afatinib, an oral,
once daily ErbB family blocker, is currently
approved in more than 60 countries for the first-line treatment of
specific types of EGFR mutation-positive NSCLC (under brand names:
Giotrif® / Gilotrif®).
*Afatinib is approved in a number of markets, including the EU, Japan,
Taiwan and Canada under the brand name GIOTRIF® and in the US
under the brand name GILOTRIF® for use in patients with
specific types of EGFR mutation-positive NSCLC. Registration conditions
differ internationally, please refer to locally approved prescribing
information. Afatinib is under regulatory review by health authorities
in other countries worldwide. Afatinib is not approved in other
indications.
For notes to editors and references, please visit:
.boehringer-ingelheim.com/news/news_releases/press_releases/2015/19_august_2015_oncology.html
Intended audiences:
This press release is issued from our Corporate Headquarters in
Ingelheim, Germany and is intended to provide information about our
global business. Please be aware that information relating to the
approval status and labels of approved products may vary from country to
country, and a country-specific press release on this topic may have
been issued in the countries where we do business.
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