Nivolumab-Alectinib-Gain-Their-First-Approvals-in-Japan - 1264810

Hi ssflxl,

Alectinib has been mentioned in a couple of GRACE videos (http://cancergrace.org/lung/tag/alectinib/ ) and mentioned briefly in a few posts.

Good to know that it seems to be showing promise.

JimC
Forum moderator

Yes, it's been alluded to here on several occasions. It seems to have activity very comparable to that of Zykadia (ceritinib), but better tolerated at the dose settled on for clinical use vs. Zykadia, which is harder to tolerate and requires dose reduction more commonly (though still has good activity after dose reduction).

The cited response rate of >90% in Japan is in a previously untreated Japanese patient population, so it's really not directly comparable to the results of other trials with other agents, particularly if patients have been previously treated. That said, it's certainly excellent, and I'd welcome having it available here in the US and elsewhere around the world.

Japan also approved the immunotherapy nivolumab for advanced melanoma today, so they're setting the pace for new drug approvals right now.

-Dr. West

My understanding is that both companies Roche (Chugai) and Bristol-Myers (Ono ) have subsidiaries that are domiciled in Japan. So I think that does impact on the approval process.

The next point, is the Japan Ministry of Health will grant approvals based on objective tumor shrinkage rather than survival in randomized phase III trials.

Finally, Japan negotiates a uniform national price schedule under their National Health Insurance, which is a universal access plan, that is much lower than what we pay in North America.

Hope this helps.

I know there's been talk before on Grace about the need to speed up/change the approval process. Is there any thought to changing overall survival for progression free? I understand there are examples of some drugs providing pfs but not overall.
What if there was a probationary time for a drug, I suppose a compassionate use sort of thing but less dependent on someone's approval.

One of the speakers for our acquired resistance forum in Boston will be Dr. Gideon Blumenthal from the US FDA, speaking on the emerging FDA perspective on changing criteria for FDA approval in molecularly defined subsets being treated with targeted therapies.

-Dr. West