Johnson & Johnson’s (J&J) blockbuster cancer immunotherapy, Darzalex (daratumumab), has secured European approval for self-administration, marking the first time an oncology injectable has achieved this milestone on the continent.
Through this Type II label change, approved by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Darzalex will now become available to European patients for either patient or caregiver administration after the fifth dose, provided the user receives proper training and a healthcare professional determines this appropriate.
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Darzalex’s label expansion applies to all ten of the drug’s approved indications –including light chain amyloidosis and smouldering multiple myeloma.
This approval from the European Medicines Agency (EMA) will deepen J&J’s dominance in the multiple myeloma indication, as the company currently has Tecvayli (teclistamab), Carykti (ciltacabtagene autoleucel) and Darzalex on the market for this disease. While Carykti and Darzalex are already blockbuster sellers for J&J, GlobalData forecasts that Tecvayli will also reach this status by 2026 – primarily driven by its forecasted move to earlier lines of relapsed multiple myeloma in combination with Darzalex.
According to Israel Stern, healthcare analyst at GlobalData, the ability to shift the administration site of care for Darzalex from the clinic to the home could eliminate “dozens of visits over the course of treatment”, while also reducing barriers to the drug’s use.
As the intravenous formulation edges closer to patent expiry, Stern adds that subcutaneous Darzalex’s at-home administration advantage can provide a “degree” of near-term protection against biosimilar erosion.
A patient-based forecast from GlobalData, parent company of Pharmaceutical Technology, predicts that Darzalex’s sales will peak in 2028 at a value of $7.6bn, before experiencing a steady decline to $5.4bn by the end of the forecast period in 2032. This sales drop will primarily be driven by growing market competition from other therapies, including monoclonal antibodies (mAb), which are forecasted to make up half of the total sales in this indication across the eight major markets (8MM: the US, France, Germany, Italy, Spain, UK, Japan and China) in 2032.
Taking on the multiple myeloma market
Currently, Darzalex is part of a standard of care (SoC) regimen across several multiple myeloma treatment contexts, including the frontline setting. In this circumstance, both transplant-eligible and ineligible patients commonly receive Darzalex with other therapies like Velcade-Revlimid-dexamethasone (VRd) or Velcade-thalidomide-dexamethasone (VTd).
The multiple myeloma market is set to reach a value of $29.9bn in 2032, as per a report from GlobalData. Analysts predict that total market sales will experience a distribution shift towards the second line of therapy or later, due to approvals of drugs like Carvykti and Tecvayli.
