Merck’s Keytruda® Receives Its Fourth FDA Breakthrough Designation

Even so, BMS’s Opdivo® is stll generally out ahead in immuno-oncology.

The new FDA suplemental biological license breakthrough designation — this time, for relapsed classical Hodgkin lymphoma, a blood cancer — is very good news for Kenilworth.

As more and more cancer patients, with varying cancer types are shown to benefit from this new class of immuno-oncology agents, diagnostic testing (to best match the sort of protien a patient’s tumors express, to the intended biologic) will be ever more important. These treatments are very pricey, and in some cancers only one-third of the patients experience most of the benefits — due to these protien expression differences. Payers have already taken copious note of these biological (genetic) facts.

Here’s a bit from, but do go read it all:

. . . .The FDA gives a drug “breakthrough” status when preliminary clinical evidence indicates that the medicine may demonstrate substantial improvement over existing therapies. Once a drug is designated as breakthrough therapy, the FDA will expedite the development and review of that drug. . . .

[Exactly a year ago, the company reported its NSCLC breakthrough designation, and related FDA filing.] Onward, on a fine Spring morning, then! Smile. . .


There are no comments on this post.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

%d bloggers like this: