Janssen submits NDA for "breakthrough" leukemia and lymphoma drug ibrutinib
Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted a New Drug Application to the US Food and Drug Administration for its “breakthrough” cancer drug ibrutinib.
The drug is under development with Pharmacyclics (Nasdaq: PCYC), which licensed ibrutinib to Janssen in a deal involving an upfront $150 million plus a potential $825 million milestone payments ( The Pharma Letter December 9, 2011).
It is intended to be used in the treatment of previously treated patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and for its use in the treatment of previously treated patients with mantle cell lymphoma (MCL).
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