Darzalex combination therapy granted reimbursement

Darzalex combination therapy is for the treatment of relapsed multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that Darzalex (daratumumab) combination therapy has been approved for reimbursement in Ireland for the treatment of adult patients with relapsed multiple myeloma (RMM) who have received at least one prior therapy.

The approval is for the use of daratumumab in combination with bortezomib (Velcade) and dexamethasone, referred to as DVd.

Multiple myeloma (MM) is a blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.

Although treatment may result in remission, patients will most likely relapse as there is currently no cure. Patients who relapse after treatment with standard therapies, including proteasome inhibitors (PIs) and immunomodulatory agents, have poor prognoses and few treatment options available.

Dr Gerard Crotty, Consultant Haematologist, Midland Regional Hospital said: “Multiple myeloma unfortunately remains a relapsing-remitting disease. After first relapse, patients’ response to treatment is likely to decrease with subsequent lines of treatment. This makes it essential to use the most effective treatments as early as possible to delay relapse and maximise overall survival.”

“There is currently a huge unmet need of treatments for patients who have relapsed, so daratumumab in combination is a long-awaited additional treatment option, which we anticipate being significant for myeloma patients,” he added. “The new subcutaneous formulation will also help reduce the level of time spent in hospital for patients which is more important now against the backdrop of Covid-19 and the need to limit as much as possible, time spent in hospital for vulnerable patients.”

DVd was granted marketing authorisation by the European Commission (EC) in April 2017 based on data from the Phase III CASTOR (MMY3004) study, initially presented at the plenary session at ASCO (American Society Clinical Oncology) 2016 and also published in the New England Journal of Medicine in August 2016.

The reimbursement of DVd follows the announcement by Janssen Sciences Ireland in July 2020 of the reimbursement of Darzalex subcutaneous (SC) formulation for the treatment of adult patients with MM in Ireland for all current daratumumab approved indications.

Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous formulation.

“We are excited to take another important step forward in further developing daratumumab, and its benefit as a backbone therapy in multiple myeloma treatment in Ireland,” said Laurent de Saint Sernin, General Manager Commercial Operations, Janssen Sciences Ireland UC. “With today’s approval and the continued development of daratumumab in six indications since 2016, we hope to bring this therapy to many more patients at a critical time in their disease pathway.”

The initial European Commission marketing authorisation was granted in May 2016 for daratumumab as monotherapy for the treatment of adult patients with relapsed and refractory MM, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

It was approved by the European Medicines Agency under an accelerated assessment, a process reserved for medicinal products expected to be of major public health interest, particularly from the point of view of therapeutic innovation.


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