Johnson & Johnson submitted an application with the European Medicines Agency seeking approval to expand the indication of blood cancer therapy Darzalex.
The New Brunswick, N.J.-based company is applying for an expanded EU nod for Darzalex, in combination with Celgene Corp.'s Revlimid and dexamethasone for treating newly diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and autologous stem cell transplant. Multiple myeloma is an incurable blood cancer that forms in plasma cells, which are responsible for producing antibodies.
Autologous stem cell transplant, a process where a patient's own stem cells are taken from the bone marrow before transplanting it back in a later time, is a standard treatment for patients with the disease.
The application is based on data from a 737-patient phase 3 study, called Maia, which showed that the Darzalex combination prolonged the life of patients without the disease getting worse — a metric known as progression-free survival.
J&J unit Janssen Biotech Inc. licensed Darzalex, or daratumumab, from Copenhagen-based drugmaker Genmab A/S in 2012.
Darzalex is already indicated in the EU in combination with either Revlimid or Takeda Pharmaceutical Co. Ltd.'s Velcade and dexamethasone for treating adults with multiple myeloma who have received at least one prior therapy.
The therapy is also used in Europe in combination with Velcade, melphalan and prednisone for treating adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant and as a single therapy for certain adults with relapsed and refractory multiple myeloma.
Darzalex is also approved in the U.S. and Japan for a variety of multiple myeloma indications. In May 2018, Johnson & Johnson halted two clinical trials for Darzalex — one for lung cancer and another for blood cancer — following a review by a data monitoring committee.
An estimated 160,000 people were diagnosed with multiple myeloma in 2018.