Eight months after Johnson & Johnson committed to a $1.1 billion deal package to partner on Genmab's cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.
Already sky-high expectations for the experimental cancer drug ibrutinib from J&J and Pharmacyclics managed to arc even higher this morning after the collaborators spread word that the program had just won its third "breakthrough drug" title from the FDA.
Johnson & Johnson scored a major victory with the FDA this month when the agency put its breakthrough designation on an investigational cancer drug, and now Abbott Laboratories is stepping in to develop a companion diagnostic for the headline-grabbing compound.
Johnson & Johnson ($JNJ) and Pharmacyclics ($PCYC) nabbed the FDA's new breakthrough designation for their cancer drug ibrutinib.
J&J and Pharmacyclics nabbed the FDA's new breakthrough designation for their cancer drug ibrutinib, a promising late-stage therapy that will be put in the hands of regulators later this year.
Pharmacyclics' closely watched leukemia drug ibrutinib has been attracting some strong buzz recently.
Partnered with J&J in a major market deal, Pharmacyclics demonstrated fresh evidence that ibrutinib could control malignancies in patients who were both treatment naïve and unresponsive to other meds.
J&J stepped in with a blockbuster licensing deal for Pharmacyclics' late-stage blood cancer drug ibrutinib late last year, and ever since it's been keeping up a rich flow of milestone payments promised in the $975 million deal.
Late last year Pharmacyclics turned heads around the industry when J&J announced that it was paying $150 million upfront to license rights to a Btk inhibitor with blockbuster potential as a new therapy for blood cancers. And J&J has kept the money flowing. Today Pharmacyclics snagged its second $50 million milestone from its rich development pact, which totals $975 million.
Anyone looking for a solid reason why J&J's Janssen would pay $150 million upfront to partner on Pharmacyclics' experimental blood cancer drug need look no further than the leukemia data the