news
FDA accepts for review a new sBLA for Keytruda in NSCLC
8 March 2016 | By Victoria White
The FDA has accepted for review a new supplemental Biologics License (sBLA) for Merck’s Keytruda (pembrolizumab) to include data from KEYNOTE-010...
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Lung cancer
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CHMP adopts positive opinion of Opdivo in NSCLC and RCC
26 February 2016 | By Victoria White
Both indications are supported by Phase 3 studies in which Opdivo demonstrated a survival benefit versus a standard of care...
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EC grants marketing authorisation to necitumumab in NSCLC
24 February 2016 | By Victoria White
This is the first authorisation for necitumumab in Europe and follows US Food and Drug Administration (FDA) approval in November 2015...
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Alecensa trial stopped early; meets primary endpoint
10 February 2016 | By Victoria White
The study showed that patients with NSCLC lived significantly longer without disease worsening when treated with Alecensa compared to crizotinib...
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Gilotrif to gain ground in the NSCLC treatment markets outside the US
9 February 2016 | By Victoria White
An analyst from GlobalData says promising clinical trial data for Gilotrif (afatinib) will strengthen the drug’s position in NSCLC treatment markets outside the US...
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EC approves osimertinib in EGFR T790M mutation-positive NSCLC
3 February 2016 | By Victoria White
The European Commission (EC) has granted conditional marketing authorisation for AstraZeneca's Tagrisso (AZD9291, osimertinib) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
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EC approves two new indications for Lilly’s ramucirumab
28 January 2016 | By Victoria White
The European Commission has approved two new indications for Lilly’s Cyramza (ramucirumab): one in patients with NSCLC and the other in patients with mCRC...
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Afatinib demonstrates superior PFS to gefitinib in NSCLC trial
27 January 2016 | By Victoria White
Results from the LUX-Lung 7 trial demonstrated superiority in progression-free survival and time to treatment failure with Boehringer Ingelheim’s Giotrif/Gilotrif (afatinib) versus Iressa (gefitinib)...
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SCLC treatment market value to rise to $2.29b by 2024, says GlobalData
22 January 2016 | By Victoria White
GlobalData states that the impressive growth will primarily be driven by the launch of premium-priced therapies, including anti-PD-1 and anti-CTLA-4 immunotherapies and targeted agents...
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Incyte and AstraZeneca announce new lung cancer trial collaboration
11 January 2016 | By Victoria White
Incyte and AstraZeneca are to evaluate the efficacy and safety of Incyte's INCB39110 in combination with AstraZeneca's Tagrisso (osimertinib) as a second-line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the…
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Pembrolizumab improves survival in PD-L1 expressing NSCLC
21 December 2015 | By Victoria White
MSD has announced results from the Phase 2/3 KEYNOTE-010 study of Keytruda (pembrolizumab) in patients with previously treated non-small cell lung cancer (NSCLC)...
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FDA grants Breakthrough designation for BI 1482694 in lung cancer
21 December 2015 | By Victoria White
BI 1482694 is Boehringer Ingelheim’s 3rd-generation, epidermal growth factor receptor mutation-specific tyrosine kinase inhibitor...
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CHMP issues positive opinion for Tagrisso (osimertinib)
18 December 2015 | By Victoria White
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of AstraZeneca’s Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small…
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Adaptimmune initiates Phase I/II T-cell therapy study in NSCLC
18 December 2015 | By Victoria White
This will be the first study of Adaptimmune’s unpartnered affinity enhanced T-cell therapy targeting MAGE-A10, a highly immunogenic member of the MAGE-A family of cancer testis antigens...
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FDA approves Roche’s Alecensa for ALK-positive NSCLC
14 December 2015 | By Victoria White
Alecensa (alectinib) is approved for patients whose disease has worsened after, or who could not tolerate treatment with Xalkori (crizotinib)...
