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Opdivo® and Yervoy® combo increases mesothelioma survival
Opdivo and Yervoy displayed a 23 percent survival rate at three years compared to 15 percent with chemotherapy, Phase III trial shows.
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EMA recommends 11 new medicines for approval following July meeting
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
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FDA grants priority review to selpercatinib New Drug Application
Priority review has been given to the NDA for selpercatinib to treat advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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Durvalumab improves survival of non-small cell lung cancer patients
Moffitt researchers conducted a Phase III trial which found durvalumab to increase the survival of patients with non-small cell lung cancer...
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New cancer immunotherapy drugs rapidly reach patients after approval
The majority of patients eligible for cancer immunotherapy drugs known as checkpoint inhibitors received treatment within a few months of FDA approval, according to a new Yale-led study.
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FDA expands approval of Imfinzi to reduce the risk of NSCLC progression
The FDA has approved Imfinzi for the treatment of patients with stage III non-small cell lung cancer whose tumours are not able to be surgically removed and whose cancer has not progressed after treatment...
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EMA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated NSCLC
The EMA has accepted a variation to the MAAv for Tagrisso, for the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer...
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FDA grants breakthrough therapy designation to Tagrisso for NSCLC
The FDA has granted Breakthrough Therapy Designation for Tagrisso for the 1st-line treatment of patients with NSCLC...
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Alcohol aversion drug disulfiram may combat chemotherapy resistance
Alcohol aversion drug disulfiram may combat chemotherapy resistance in non-small cell lung cancer...
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Imfinzi wins breakthrough therapy designation
AstraZeneca and MedImmune, have today announced that the US Food and Drug Administration has granted breakthrough therapy designation for Imfinzi for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer...
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AstraZeneca’s lung cancer drug receives full approval in the EU
27 April 2017 | By Niamh Marriott, Junior Editor
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-small cell lung cancer (NSCLC).
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AstraZeneca lung cancer drug receives FDA approval
4 April 2017 | By Niamh Marriott, Junior Editor
The US Food and Drug Administration (FDA) has granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR…
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NICE recommends five drugs to treat four different conditions
The National Institute for Health and Care Excellence (NICE) has published final guidance recommending that five drugs to treat four different conditions should be routinely funded by the NHS.
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Expanded Phase II trial of savolitinib in NSCLC starts
20 June 2016 | By Victoria White, Digital Content Producer
A Phase II expansion of the ongoing TATTON trial has been initiated to evaluate savolitinib (AZD6094) in epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) patients.
