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J&J grabs another 'breakthrough' FDA win with early-stage cancer drug

Eight months after Johnson & Johnson ($JNJ) committed to a $1.1 billion deal package to partner on Genmab"s cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.


The drug--which targets the CD38 molecule expressed on the surface of multiple myeloma cells--is still early enough in the development process to potentially benefit significantly from the agency"s adoption effort for promising experimental therapies. While still in its early stages, executives on these programs are promised open doors and quick responses from the FDA in order to hurry the process--potentially clipping months or years off the development cycle.


J&J had already claimed boasting rights for breakthrough status for ibrutinib, a closely-watched cancer drug now in late-stage development with Pharmacyclics ($PCYC), back in February. Both of J&J"s breakthrough drugs were snagged in billion-dollar deals, the kind of classic, major-league partnerships that J&J likes to use to snare big new assets with blockbuster potential. 

The lengthening list of breakthrough announcements indicates the FDA is particularly drawn to therapies that have a Big Pharma chaperone. The FDA"s comfort zone also reflects a big attraction to cancer therapies. But just yesterday little Durham, NC-based ScioDerm stepped up to join the ranks with the big boys, pointing the way for other small biotechs yearning to gain the inside regulatory track.


"Breakthrough designation allows us to work together with our strategic partner Janssen and the FDA to expedite the development of daratumumab in multiple myeloma, so patients suffering from this devastating type of blood cancer could potentially receive access to this medicine much sooner," said Jan van de Winkel, the CEO of Genmab, in a statement


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