Loxo Edges Closer To Commercial Market With Larotrectinib, But Diagnostic Challenge Persists
Loxo impressed at ASCO last year with larotrectinib, which has now been accepted by FDA for priority review with a PDUFA date of Nov. 26, and the oncology drug developer could shine again this year. If approved, however, larotrectinib could launch ahead of its companion diagnostic.
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New oncologics bring CDER’s novel agent approvals count to 53 for the year.
More Good News For Bayer's Larotrectinib Ahead Of FDA Verdict
An update on Bayer and Loxo's tissue-agnostic therapy for cancers with NTRK gene fusions has impressed, confirming the sustained durable effect of larotrectinib as it nears its action date for approval in the US.
New EU Speedy Review Hopefuls: Novimmune, AveXis, bluebird bio, and Loxo Oncology
It is not easy for companies to convince the European Medicines Agency that their marketing applications merit accelerated assessment. Four new hopefuls are about to find out whether they have been successful.