Pharmacyclics bounces higher as J&J wins third 'breakthrough' cancer drug coup

Already sky-high expectations for the experimental cancer drug ibrutinib from J&J ($JNJ) and Pharmacyclics ($PCYC) 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. This latest regulatory score is for their work on patients with chronic lymphocytic leukemia or small lymphocytic lymphoma whose cases are marked by a fatal deletion in chromosome 17--which is typically a death sentence.

The developers have already won breakthrough status for a pair of B-cell malignancies. And while it's still early days for the FDA's new effort to move some of the most promising new therapies to the head of the regulatory class, in theory at least these treatments are supposed to be fast-tracked through clinical development, with the FDA waiting eagerly at the end of a shortened race track. In practice, though, it's still too early to tell exactly how this new designation will play out for drug companies.

J&J and Pharmacyclics, though, will likely learn a lot more about this process as they push ahead with an ongoing Phase II study for this group of patients with deletion 17p--when the short arm of chromosome 17 is missing, interfering with the tumor suppressor gene TP53. Earlier this year investigators began recruiting 111 patients for the midstage program, looking for people who had already failed a prior treatment and have little hope of surviving long.

If the FDA intends to speed up the approval process for ibrutinib, which some analysts fervently believe can fetch up to $5 billion a year in revenue, regulators will need to catch up with investigators. In typical J&J fashion, the aggressive pharma giant has mapped out 26 clinical trials for ibrutinib after landing a pricey $1 billion partnership. The drug is in 5 Phase III studies already, and Pharmacyclics' shares, already swollen as the market cap broke through the $5 billion mark, skipped up another 5% this morning. 

Late last week David Shaywitz, a contributor at Forbes, published a lengthy piece on the origin of ibrutinib.

- here's the press release