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FDA grants approval to Merck & Co.'s Keytruda as first-line combination therapy in NSCLC
firstwordpharma
May 11, 2017
Merck & Co. announced Wednesday that the FDA awarded accelerated approval to Keytruda (pembrolizumab), in combination with Eli Lilly's Alimta (pemetrexed) and carboplatin.
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AstraZeneca’s lung cancer drug receives full approval in the EU
europeanpharmaceuticalreview
April 28, 2017
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-smal
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Novartis drug combination Tafinlar + Mekinist receives EU approval for BRAF V600-positive advanced N
cphi-online
April 05, 2017
New indication of Tafinlar and Mekinist in advanced NSCLC provides only therapy approved in the EU for BRAF V600-positive NSCLC.
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BerGenBio and Merck to evaluate BGB324 with Keytruda in NSCLC and breast cancer
pharmaceutical-technology
March 13, 2017
Norwegian-based biopharmaceutical company BerGenBio has signed an agreement to clinically evaluate its lead candidate BGB324 with Merck’s Keytruda (pembrolizumab) in patients with advanced non-small-cell lung cancer (NSCLC) and triple-negative breast canc
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Novartis receives positive CHMP opinion for Tafinlar + Mekinist in BRAF-positive NSCLC patients
cphi-online
February 28, 2017
If approved, Tafinlar + Mekinist will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation.
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Novartis drug Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastat
worldpharmanews
February 24, 2017
Novartis today announced that the US Food and Drug Administration (FDA) accepted the Company's supplemental New Drug Application (sNDA) for filing.
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Merck gets the thumbs up in Europe for Keytruda to treat patients with metastatic NSCLC
cphi-online
February 06, 2017
First anti-PD-1 therapy approved in Europe for previously untreated patients with metastatic NSCLC.
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AstraZeneca broadens first-line immuno-oncology NSCLC development programme
firstwordpharma
January 18, 2017
AstraZeneca provided an update Tuesday on its late-stage immuno-oncology development programme in first-line non-small-cell lung cancer (NSCLC).