Janssen’s PBS listed multiple myeloma therapy to cut treatment time from hours to minutes

Pharma News: Experts in the treatment of multiple myeloma are welcoming Federal Government funding for a new intravenous formulation which cuts administration time from hours to just minutes.

Darzalex SC (daratumumab solution for injection), available on the Pharmaceutical Benefits Scheme (PBS) from 1 November, is indicated for the treatment of multiple myeloma in combination with Takeda’s Velcade (bortezomib) and corticosteroid dexamethasone, after one prior line of therapy.

Professor H. Miles Prince AM, Director of Molecular Oncology and Cancer Immunology, Epworth Healthcare and of the Centre for Blood Cell Therapies at the Peter MacCallum Cancer Centre, said the new formulation is a “win-win-win for patients, clinicians and infusion centres”.

“Efficacy and safety will always be the number one reason doctors select one treatment over another, but when efficacy and safety are combined with convenience it is an appealing combination,” he said.

“Darzalex SC has similarly impressive efficacy and safety profiles as the intravenous formulation, but cuts treatment time from hours to minutes. They can spend less time being a cancer patient,” Professor Prince added.

Darzalex SC is injected by a doctor or nurse in approximately 3-5 minutes. This compares to approximately 7.0 hours for the first infusion, 4.3 hours for the second infusion and 3.5 hours for subsequent infusions with the intravenous formulation of Darzalex. The time-savings offered by Darzalex SC are significant, with a newly initiated patient expected to reduce their treatment time by at least 70 hours in the first year alone.

“Less time spent in hospital will also be an advantage for many cancer patients who are doing their best to reduce potential exposure to COVID-19,” Professor Prince added.

Time-savings also add up for infusion centres with the possibility of almost 80,000 hours in infusion chairs saved in the next year alone, based on approximately 1,000 multiple myeloma patients being eligible for Darzalex SC through the PBS. This equates to a 97% decrease in estimated infusion chair time with Darzalex SC compared with the intravenous formulation, and 63.8% decrease in healthcare professional time.

Professor Prince added that, “Like the subsidy for intravenous Darzalex, the PBS listing for Darzalex SC only applies after a patient has had one prior line of treatment – making it important that patients are offered Darzalex SC early on.”

In clinical trials, Darzalex SC demonstrated a consistent response rate and pharmacokinetics, and a similar safety profile compared with intravenous Darzalex in patients with newly diagnosed and relapsed or refractory multiple myeloma, including in combination with standard of care regimens. This means that clinicians treating multiple myeloma patients at first relapse with Darzalex SC alongside Velcade/dexamethasone (Vd) can expect an estimated 78% relative risk reduction in disease progression or death, similar to that achieved with Darzalex IV when used in combination with Velcade/dexamethasone. Median progression free survival with the intravenous Darzalex combination was 27 months compared with 7.9 months in patients treated with Vd alone. (p<0.0001; post-hoc analysis).

Janssen Australia and New Zealand Managing Director, Biljana Naumovic said, “At Janssen, we are constantly working to improve the lives of patients and believe this innovation will transform the treatment experience for many patients, freeing them up to spend more time doing the things they enjoy,” she said.

“Our company has a long and proud history in the treatment of multiple myeloma. The PBS listing of Darzalex SC further demonstrates our leadership in the treatment of this and other haematologic malignancies.”
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