Johnson & Johnson’s first-in-class multiple myeloma immunotherapy Darzalex has been approved in Europe, joining an increasingly competitive market.
Anti-CD38 monoclonal antibody Darzalex (daratumumab) has been cleared as a monotherapy for adults with relapsed and refractory multiple myeloma under the EU’s accelerated assessment protocol.
The drug – which was first approved by the US FDA last November – is indicated for patients whose disease has progressed despite prior treatment with a proteasome inhibitor (PI) such as Takeda’s Velcade (bortezomib) and an immunomodulatory agent like Celgene’s Revlimid (lenalidomide).
Approval was based on the results of the phase II SIRIUS trial, which showed daratumumab achieved a 65% one-year overall survival rate and nearly 30% objective response rate in patients with ‘double refractory’ multiple myeloma, as well as data from the phase I/II GEN501 study.
Darzalex enters a market that has been transformed in recent years by a swathe of new myeloma therapies, including most recently Takeda’s orally-active PI Ninlaro (ixazomib), Novartis’ HDAC inhibitor Farydak (panobinostat) and SLAMF7 inhibitor Bristol-Myers Squibb’s Empliciti (elotuzumab).
These new products are expected to help drive the global market for multiple myeloma therapies from $8.9bn in 2014 to an estimated $22.4bn by 2023, according to GlobalData.
The market research firm predicts Empliciti could reach peak sales of $4.2bn, ahead of Darzalex with sales of $3.7bn in that year. Sales of Darzelex in the US reached more than $100m in its first six months on the market, and it is predicted to make $400m-$450m in 2016.
“Despite recent advances, multiple myeloma remains a complex, incurable disease, with relapse being inevitable in almost all patients,” said Professor Jesús San Miguel of the Universidad de Navarra, Spain, a myeloma specialist.
“With each relapse, the disease typically becomes more aggressive and more challenging to treat,” he added, noting that Darzalex’ impact on survival is a significant advance for a patient group whose prognosis is typically “very poor”.
Darzalex – originally developed by Denmark’s Genmab – is currently in a phase III trial comparing the combination of the antibody with bortezomib and dexamethasone to bortezomib and dexamethasone alone, and achieved a significant increase in progression-free survival (PFS) at an interim analysis.
The results – which reveal a 61% reduction in the risk of disease progression – are scheduled for presentation at the American Society of Clinical Oncology (ASCO) conference next month.