Johnson & Johnson, Pharmacyclics' Imbruvica garners FDA approval for mantle cell lymphoma

The FDA announced Wednesday the approval of Johnson & Johnson and Pharmacyclics' Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. The agency noted that the drug, which was granted priority review in August, is the second with breakthrough therapy status to receive FDA clearance. "Imbruvica's approval demonstrates the FDA's commitment to making treatments available to patients with rare diseases," remarked Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

The approval was based on a clinical trial of 111 patients with previously treated MCL who received Imbruvica until disease progression or the development of intolerable side effects. Study data showed that 65.8 percent of patients experienced tumour shrinkage or disappearance after treatment with the drug, while the median duration of response was 17.5 months. Pharmacyclics noted that an improvement in disease-related symptoms or survival has not been established.

The companies have also submitted Imbruvica for approval for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma, for which a decision from the FDA is still pending. Provided the drug garners additional approvals, RBC Capital Markets analyst Michael Yee projects sales of the therapy of $6.5 billion in 2026 including $3 billion in US revenue.

Pharmacyclics said Imbruvica is commercially available immediately.

To read more Top Story articles, click here.