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

Onyx’s Myeloma Drug Kyprolis Fits ODAC’s View On Accelerated Approval

Executive Summary

FDA’s Oncologic Drugs Advisory Committee overwhelmingly endorsed the second-generation proteasome inhibitor for accelerated approval in the relapsed/refractory population. Onyx’s reliance on a single-arm study was appropriate given the lack of treatment options in a heavily pre-treated population, said ODAC members, who also looked favorably upon the company’s advanced plans for confirmatory trials.

You may also be interested in...



Puma Breaks A Long Losing Streak For Sponsors At ODAC

Puma is in select company after winning a strong vote from US FDA’s Oncologic Drugs Advisory Committee in favor of approval of its new cancer drug neratinib.

Novartis’ Panobinostat Review Panel Could Scrutinize Survival Data

FDA’s Oncologic Drugs Advisory Committee is slated to meet on Nov. 6 to consider Novartis’ HDAC inhibitor panobinostat for relapsed multiple myeloma and may also look closely at dosing issues.

Navigating A Patient Centered World: What Works, What Doesn’t

Patients and patient foundations have become sophisticated players in the funding and translation of early stage medicines. Panelists at FasterCures’ Partnering for Cures conference shared some of the challenges that still remain in how patient groups and other stakeholders can best maximize partnership opportunities.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054543

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