[Lev]

Farydak (Panobinostat) now available in Denmark

by Lev on Fri Dec 04, 2015 6:34 am

As previously reported here at the Myeloma Beacon, Farydak (panobinostat) was approved for treatment of multiple myeloma in the US in February this year.

From December 7th it will also be approved for use in Denmark. The patients must previously have had at least two of the approved standard treatments without effect or followed by return of the cancer.

So far it is not approved as a first-line treatment.

Best regards,

Lev

Link to related Novartis press release (in Danish):

http://www.mynewsdesk.com/dk/novartis-oncology/pressreleases/nyt-laegemiddel-mod-myelomatose-klar-til-danske-patienter-1267230?view_policy=1

[Boris Simkovich]

Re: Farydak (Panobinostat) now available in Denmark

by Boris Simkovich on Fri Dec 04, 2015 12:07 pm

Hi Lev,

Thanks for this update.

One point worth clarifying, however, is that Farydak has been approved for use in Denmark since it was approved by the European Commission this September (see this forum posting about the approval). In the EU, the review and approval of cancer therapies is a centralized procedure done by the European Medicines Agency, with final decisions made by the European Commission. These decisions are then valid throughout the EU and also in Iceland, Lichtenstein, and Norway.

Once a drug is approved through the centralized procedure, the company selling the drug begins the process of officially launching the drug in specific countries within the EU. The timing of these launches can depend on supply-related issues as well as reimbursement and pricing decisions, which can stretch the process out for months at a time.

In the Danish case, I believe there are no reimbursement or pricing approvals that are necessary for a new drug to launch. So Novartis waited until now to make the drug available in Denmark for supply and other reasons.

In any case, it's certainly good news for Danish myeloma patients that the drug is now a treatment option for them.