Pharmacyclics seeks additional indication for Imbruvica in USA

USA-based Pharmacyclics (Nasdaq: PCYC) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration to gain a wider indication for its mantle cell lymphoma (MCL) treatment Imbruvica (ibrutinib).

The filing is based on data from the randomized, multi-center, open-label Phase III RESONATE study, PCYC-1112, a head-to-head comparison of single agent Imbruvica) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy.

Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of US health care giant Johnson & Johnson (NYSE: JNJ). The deal with Janssen involved $150 million upfront and further potential payments of $825 million to Pharmacyclics.