Johnson & Johnson’s Janssen division has received an extended marketing authorisation from the European Commission for a new triple regimen of Darzalex (daratumumab) in multiple myeloma.
The new approval means that Darzalex, in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone, (DRd) can be administered for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).
Darzalex is already approved in combination with bortezomib, melphalan and prednisone to treat adult patients with newly diagnosed multiple myeloma who are ineligible for ASCT.
The new formulation was approved based on the results from the phase 3 MAIA study, which showed that the Darzalex combination significantly reduced the risk of disease progression or death by 44% compared to treatment with Revlimid and dexamethasone (Rd) alone.
At 28 months the median progression-free survival (PFS) for the Darzalex combination had not yet been reach, compared to 31 months for patients who received Rd alone.
The addition of Darzalex also demonstrated deeper responses compared to Rd alone, including increased rates of complete response or better – 48% compared to 25%.
“Every year over 48,000 people in Europe are diagnosed with multiple myeloma, which is considered to be incurable,” said Patrick Laroche, haematology therapy area lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag.
“Older patients who are ineligible for transplant have a limited range of frontline therapeutic options available, so we are pleased that with today’s approval of daratumumab-Rd, these patients now have a new frontline option available to them,” he added.
Janssen could however face competition in the myeloma therapy area as soon as April next year – Sanofi has filed its rival drug isatuximab as a treatment for relapsed/refractory multiple myeloma with the FDA, with a standard ten-month review and action date of 30 April 2020.
The phase 3 ICARIA-MM trial demonstrated that the drug could prolong PFS, but there was only a trend towards improved overall survival – although that data isn’t mature yet.
However, the FDA’s standard review time suggests that it does not view the drug as an advance over Darzalex.
More competition could also come from MorphoSys and Takeda, which both have anti-CD38 drugs in late-stage studies for myeloma. Bristol-Myers Squibb and AbbVie’s already-marketed Empliciti (elotuzumab) is also vying for a larger market share in myeloma.