La Nueva Aprobación hace que Darzalex sea el Primer Medicamento con Anticuerpos Aprobado en Primera Línea .
3rd September 2018
Johnson & Johnson’s Darzalex is to take a more central role in multiple myeloma treatment following its European approval in a new frontline combination.
Its pharma division Janssen has gained EU approval for its use alongside Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) for newly-diagnosed myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant (ASCT), a key front-line treatment strategy.
The approval is based on the results of the ALCYONE clinical trial, which shows that adding Darzalex to VMP cuts the risk of disease progression or death by 50% in these patients.
The EU approval follows a nod from the FDA in May, and this frontline use will add extra impetus to the drug, which is already enjoying rapid growth. Sales nearly doubled in the second quarter compared to the same period last year, up to $511m in the second quarter ($298m in the US and $213m in the rest of the world).
First-line use will be the next growth driver for the intravenous anti-CD38 monoclonal antibody, initially based on the comparison with VMP, which showed the new drug reduced the risk of disease progression or death by 50%. The median progression free survival (PFS) for daratumumab-VMP had not yet been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone. ...