Genmab — Maj 2021

JørgenVarnæs

It’s the EGFR “subset” of nscl that cannot be considered well-defined

E_L

yes, i would say it is a fair argument by EMA, we'll see if JNJ will appeal, but it is good that it is clarified, ie. the reason is not effectiveness or something like that, on the contrary, EMA seemed rather positive about the drug

JørgenVarnæs

I do find the EMA argumentation a bit confusing

E_L

my interpretation is that JNJ tried to narrow the definition of the targeted disease to a small subsector of NSCLC in an attempt to get orphan status; in a nutshell: EMA rejects that subsector definition

E_L

and NSCLC is too large a disease to fall under orphan

Bulder

I don't know how important an orphan designation is? Gives some priviliges, but else?

Bulder

Sponsors who obtain orphan designation benefit from protocol assistance, a type of scientific advice specific for designated orphan medicines, and market exclusivity once the medicine is on the market. Fee reductions are also available depending on the status of the sponsor and the type of service required. https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation-overview

Bulder

The prevalence must not be more than 5 in 10.000, so they (Janssen) tried in vain to narrow it in.

Bulder

As I see it "market exclusivity" is most important. A good thing to have of course, but not nescessary.

Sukkeralf

Agree

Sukkeralf

Here were it is the first indication they go after its almost of no importance

E_L

i agree it is mainly about market exclusivity , but i do think that can be important with the rapid development of copy cats and generics. But i agree that it would only be for a small part of the market they may eventually target, as we know that they wouldn't get orphan for the whole NSCLC indication (if they decide to go for that broader label)

Sukkeralf

Amgen saw two cases of peripheral polyneuropathy in a 42-subject study of its rival bispecific AMG 420. The BCMA bispecific is no longer featured in Amgen’s pipeline.