Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Loxo Edges Closer To Commercial Market With Larotrectinib, But Diagnostic Challenge Persists

Executive Summary

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.

You may also be interested in...



Vitrakvi, Daurismo Approvals Put US FDA On Brink Of Another Record

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC123165

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel