Astellas Files Personalized Tarceva In First-line Lung Cancer With FDA
This article was originally published in The Pink Sheet Daily
If successful, filing in EGFR-positive patients could give Roche/Astellas’ Tarceva a commercial boost, broadening erlotinib’s role in non-small-cell lung cancer.
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The Japanese pharma is consolidating its U.S. operations, including the shuttering of OSI, where Tarceva initially was developed, as the cancer drug gains another indication with a companion diagnostic.
DOTW looks at Astellas’ oncology ambitions plus its recent split with partner Ambit, as well as analysis of Shire’s buyout of Premacure, AbbVie’s out-license of an anti-interleukin-13 antibody to Receptos and the Merck/Luminex collaboration on a companion diagnostic for Alzheimer’s disease.
FDA accepts afatinib – among Boehringer’s first cancer drugs – in first-line EGFR-mutation positive non-small cell lung cancer. Filing is supported by LUX-Lung 3 study, in which the drug showed a 4.2 month progression-free survival benefit over what some describe as the most effective chemo doublet available.