Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

Medicines licensing

Panobinostat set for approval in Europe as multiple myeloma treatment

The multiple myeloma drug panobinostat has received a positive opinion from the European Medicines Agency for the treatment of relapsed and/or refractory multiple myeloma. In the image, micrograph of multiple myeloma

Source: Nephron / Wikimedia Commons

Patients with multiple myeloma that is relapsed or refractory are set to have another treatment option when panobinostat receives EU approval

The multiple myeloma drug panobinostat has received a positive opinion from the European Medicines Agency (EMA) for the treatment of relapsed or refractory disease in patients who have received at least two treatment regimens including bortezomib and an immunomodulatory agent.

Panobinostat inhibits histone deacetylase, resulting in increased acetylation of histone proteins. If approved in the EU, the drug, which is marketed by Novartis Europharm as Farydak, will be the first in its class of anticancer agents. Panobinostat was previously designated an orphan medicine in view of the rarity of multiple myeloma.

The positive opinion is based on the PANORAMA-1 trial[1], which included 768 patients with multiple myeloma who were randomly assigned to receive a combination of panobinostat, bortezomib and dexamethasone, or bortezomib and dexamethasone alone.

Patients who received panobinostat has significantly longer progression-free survival (PFS) than those who did not; overall survival data is still accruing. The most common side effects in patients receiving panobinostat were blood disorders, haemorrhage, diarrhoea, nausea, vomiting and fatigue.

Owing to the risk for severe toxicity, the EMA’s Committee for Medicinal Products for Human Use (CHMP) considered that the overall risk-benefit balance was positive only in patients with relapsed or refractory multiple myeloma who had received at least two prior regimens including bortezomib and an immunomodulatory agent.

Following the CHMP’s positive opinion, panobinostat is expected to be granted EU marketing authorisation within three months and its orphan status will be reviewed. A post-marketing plan to monitor the safety of panobinostat and lower its risks was also agreed by the CHMP. 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068868

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.