Tuesday, April 19, 2016

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 cancers, 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 Philly.com, 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. . .

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