Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Accelerated Approval Submission On The HORIZON For Oncopeptides’ Melflufen

Executive Summary

US FDA says Phase II HORIZON data in relapsed triple-class refractory multiple myeloma can support NDA; Oncopeptides aims for submission Q1 2020.

You may also be interested in...



Pepaxto’s Accelerated Approval In Myeloma May Sink On OCEAN Trial's Adverse Survival Data

US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.

Phase III Analyses Prompt Partial Clinical Hold On Oncopeptides' Melflufen Studies

Oncopeptides AB’s melflufen (Pepaxto) has met the primary PFS endpoint in the Phase III OCEAN study, designed to extend its reach into earlier-stage multiple myeloma patients, but overall survival data favors the comparator in patient subgroups, and melflufen in others, leading to regulators pausing clinical trials to review the results.

Keeping Track: Biogen’s Aducanumab Headlines Midsummer Submission Round-Up

The latest application submission news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125349

Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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