Johnson & Johnson and Pharmacyclics have submitted their 'breakthrough' blood cancer drug ibrutinib to the US Food and Drug Administration for approval.
The regulator will be assessing whether the drug can be marketed as a treatment for mantle cell lymphoma and chronic lymphocytic leukaemia/small lymphocytic lymphoma, on the back of data from two Phase II studies indicating their potential.
Ibrutinib, an oral BTK inhibitor, is one of the first medicines to file for FDA approval through the agency's new Breakthrough Therapy Designation pathway, which is intended to speed up the development and review time for a potential new medicine.
The drug has actually bagged three Breakthrough Therapy Designations by the FDA: as a monotherapy for the treatment of: patients with CLL/SLL with a particular genetic defect, patients with relapsed/refractory MCL who have received prior therapy, and patients with Waldenström’s macroglobulinemia.
The drugmakers said they are going after a priority review, in order to shorten the decision time to a six-month timeframe.
The effectiveness and safety of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, and under their 2011 agreement, J&J group Janssen Biotech and Pharmacyclics will co-commercialise the drug in the US.
Feeling on the ground is that regulators will issue a green light for the drug, which some analyst expect could make sales of up to $4 billion by 2019 across its proposed indications.