Zykadia Challenged As Roche’s Alecensa Gets EU Nod
Roche’s Alecensa gets EU nod for second-line use in ALK+ non-small cell lung cancer patients – but first-line data in 2017 will be vital.
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Expanded US approval for Alecensa in ALK-positive NSCLC will stand the product in good stead as it helps make up for upcoming biosimilar threat to Avastin, Rituxan and Herceptin.
The presentation of the full data from Novartis’ ASCEND-4 study of Zykadia show decent efficacy in first-line NSCLC but are unlikely to be enough to overcome doctors’ caution over its tolerability profile, especially with rival Alecensa snapping at its heels.
The universe seems to be working this year in favor of patients with non-small-cell lung cancer (NSCLC) – with a lot of help from drug makers and the FDA's Office of Hematology and Oncology Products.