J&J, Pharmacyclics win early approval for 'breakthrough' cancer drug ibrutinib

The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics ($PCYC) and Johnson & Johnson ($JNJ).

The agency cut months off the traditional timeline for the drug, marking another quick OK for a "breakthrough" drugs, following the approval of Roche's ($RHHBY) Gazyva two weeks ago. The drug will be marketed as Imbruvica for mantle cell lymphoma, a rare blood cancer.

In its announcement the FDA cancer czar Richard Pazdur highlighted the agency's early action on the drug.

"Imbruvica's approval demonstrates the FDA's commitment to making treatments available to patients with rare diseases," said Pazdur. "The agency worked cooperatively with the companies to expedite the drug's development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program."

The FDA has handed Breakthrough Therapy status to a slate of promising experimental therapies this year.

Goldman Sachs recently initiated coverage of Pharmacyclics by projecting peak sales of the cancer drug at $6 billion. And a number of other analysts aren't far off that mark, including some who have been significantly upping the ante here over the past 12 months.

The therapy blocks a key enzyme involved in the growth of cancer and helped control the cases of 68% of 116 patients--with a relatively improved safety profile among treatment-resistant patients. The data have driven Pharmacyclics' shares to considerable heights, making CEO Robert Duggan a paper billionaire in the process.

J&J stepped in in late 2011, providing a rich $975 million deal to collaborate on development and marketing. The move demonstrated yet again the pharma giant's expertise at executing a blockbuster deal at the right moment.

- here's the release from the FDA
- read Pharmacyclics' announcement

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.