Van de conf call van 3Q JNJ:
DARZALEX continues to gain strong acceptance as a treatment for multiple myeloma and contributed approximately 2 points of worldwide pharmaceutical sales growth.
Additionally, we have launched DARZALEX, the first of our 10 potential $1 billion-plus NMEs. DARZALEX, launched last year, is significantly outperforming expectations. According to your own models, it is well on its way to becoming a multibillion-dollar brand.
IMBRUVICA's leadership in oncology is mirrored by our recently launched asset, DARZALEX. Only three months after its launch, DARZALEX became the number one prescribed therapy in fourth line or later multiple myeloma. From a launch aligned sales perspective, DARZALEX has continued to far outpace its competitors. This first-in-class medicine has since been approved in the EU and Canada and is driving positive share trends in earlier therapy lines in the U.S. We are confident DARZALEX can become the standard of care in multiple myeloma and help even more than the 10,000 patients who have benefited already worldwide.
Growth will continue to accelerate with the anticipated approval in second-line patient populations and the impressive data from the recently published CASTOR and POLLUX studies. An additional five Phase 3 trials are currently underway as well as development of a subcutaneous formulation. As Bill will detail, we have also seen some positive data that DARZALEX may be effective outside of multiple myeloma.
Recently, we uncovered an important additional mechanism of action of DARZALEX to be immune-mediated through the depletion of immunosuppressive myeloid and lymphoid populations including a previously unrecognized super-suppressor CD38 positive T-reg population as well as activation of CD8 and CD4 positive effect to T-cells. These results provide the impetus for exploring DARZALEX in indications beyond hem-malignancies and solid tumors.
Our hem-malignancies disease area is anchored by IMBRUVICA and DARZALEX. DARZALEX, the first monoclonal antibody for the treatment of multiple myeloma, received two FDA breakthrough therapy designations and was approved almost four months ahead of its PDUFA date in double refractory myeloma. As shown on this slide, combination therapy with DARZALEX delivered impressive results in treatment of relapsed or refractory multiple myeloma patients. The CASTOR and POLLUX studies demonstrated that the addition of DARZALEX to Velcade and dexamethasone or Revlimid and dexamethasone respectively produced a greater than 60% decrease in risk of progression or death as compared to that of VelDex or RevDex alone. Both of these studies were published in The New England Journal. This month, the FDA granted priority review for Daratumumab in combination with Lenalidomide and Dexamethasone or Bortezomib and Dexamethasone for relapsed multiple myeloma with a PDUFA date in February 2017.