FDA expands approval of Johnson & Johnson, Pharmacyclics' Imbruvica for chronic lymphocytic leukaemia

The FDA announced Wednesday that it expanded approval for Johnson & Johnson and Pharmacyclics' Imbruvica (ibrutinib) to include treatment of patients with chronic lymphocytic leukaemia (CLL) who have received at least one previous therapy. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA's Center for Drug Evaluation and Research, said the clearance "provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy," adding that the review was completed under the agency's accelerated approval process.

The approval was supported by data from a Phase Ib/II trial involving 48 patients with relapsed or refractory CLL. The agency noted that, on average, participants had been diagnosed with the disease 6.7 years prior to the study and had received four previous therapies. As part of the trial, all patients received a daily oral dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results demonstrated that about 58 percent of the patients achieved an overall response rate, while the duration of response ranged from 5.6 months to 24.2 months. The FDA further noted that no improvement in survival or disease-related symptoms has been established.

Imbruvica was initially cleared by the FDA in November to treat mantle cell lymphoma in patients who have received at least one prior therapy. The companies, which had filed the Bruton's tyrosine kinase inhibitor for US approval last July, co-developed the treatment under a 2011 agreement that could be worth as much as $975 million for Pharmacyclics. Bob Duggan, chief executive of Pharmacyclics, said the expanded indication "is the first major milestone in the CLL clinical development plan, which includes seven Phase III trials…and covers all lines and various combinations of treatments."

The companies stated in January that the late-stage RESONATE study testing Imbruvica in patients with CLL or small lymphocytic lymphoma was halted early based on results showing the drug significantly improved progression-free survival, compared with GlaxoSmithKline and Genmab's Arzerra (ofatumumab). RBC Capital Markets analyst Michael Yee predicted Imbruvica could generate peak sales of $6.5 billion in 2026, including US sales of $3 billion.

For related analysis, see In Focus: Can Imbruvica revolutionise the CLL market?- Pharmacyclics, Johnson & Johnson's newest drug profiled.

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