FDA approves Johnson & Johnson, Pharmacyclics' Imbruvica for Waldenstrom's macroglobulinaemia

Johnsons & Johnson and Pharmacyclics announced Thursday that the FDA expanded approval of Imbruvica (ibrutinib) to include the treatment of Waldenstrom's macroglobulinaemia. The agency noted that Imbruvica is the first drug authorised to treat the condition. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, commented "today's approval highlights the importance of development of drugs for supplemental indications."

The companies indicated that the approval of Imbruvica was supported by data from a Phase II study of 63 patients with previously treated Waldenstrom's macroglobulinaemia. An analysis by an independent review committee revealed that the therapy was associated with a response rate of 62 percent, including very good partial response and partial response rated of nearly 11 percent and 51 percent, respectively. The companies added that the median duration of response has not been reached.

Commenting on the news, Roth Capital analyst Joseph Pantginis said that the approval of Imbruvica for this indication "continues to talk to the strength of the Imbruvica franchise." The analyst suggested that the drug could amass $987 million in revenue in 2015, roughly in line with guidance of about $1 billion.

The latest approval marks the fourth indication for which the drug has been granted market authorisation in the US following its accelerated approval for the treatment of mantle cell lymphoma in November 2013. The therapy was later cleared for the treatment of chronic lymphocytic leukaemia (CLL) and for CLL in patients who carry the 17p deletion last year.

Johnson & Johnson and Pharmacyclics co-developed Imbruvica under a 2011 agreement that could be worth as much as $975 million to Pharmacyclics.

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