Johnson & Johnson’s (J&J) blockbuster cancer immunotherapy, Darzalex (daratumumab), has received European regulatory approval, marking the first time that an oncology injection has achieved this milestone on the continent.
With this Type II label change, approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (CHMP), Darzalex will now be available to patients in Europe to be administered by the patient or caregiver after the fifth dose, provided that the user receives appropriate training and a healthcare professional determines that this is appropriate.
Darzalex’s label extension applies to all ten of the drug’s approved indications—including light chain amyloidosis and smoldering multiple myeloma.
This approval from the European Medicines Agency (EMA) will deepen J&J’s dominance in multiple myeloma indications, as the company currently has Tecvayli (teclistamab), Carykti (ciltacabtagene autoleucel) and Darzalex in the market for this disease. While Crykti and Darzalex are already J&J’s blockbuster sellers, GlobalData predicts that Tecvayli will reach this status again in 2026 – driven primarily by its predicted move in front-line relapsed multiple myeloma combined with Darzalex.
According to Israel Stern, a healthcare analyst at GlobalData, the ability to shift Darzalex’s administration from the clinic to the home could eliminate “numerous visits during treatment”, while also reducing barriers to drug use.
As the intravenous formulation nears patent expiration, Stern adds that Darzalex’s home-administered benefit could provide a “degree” of near-term protection against biosimilar failures.
A patient-based forecast from GlobalData, the parent company of Pharmaceutical Technologypredicts that sales of Darzalex will increase by 2028 to a value of $7.6bn, before experiencing a further decline to $5.4bn by the end of the forecast period in 2032. This decline in sales will be primarily driven by increased market competition from other therapies, including monoclonal antibodies that will account for the total sales of monoclonal antibodies in the eight largest markets (8MM: US, France, Germany, Italy, Spain, UK, Japan and China) by 2032.
Currently, Darzalex is part of the standard of care (SoC) in all multiple myeloma treatment settings, including in the front-line setting. In this situation, both transplant-eligible and ineligible patients often receive Darzalex and other therapies such as Velcade-Revlimid-dexamethasone (VRd) or Velcade-thalidomide-dexamethasone (VTd).
The multiple myeloma market is expected to reach a value of $29.9bn by 2032, according to a report from GlobalData. Analysts predict that the total market sales will receive a change in distribution to the second line of treatment or later, due to the approval of drugs such as Carvykti and Tecvayli.
“IJ&J’s Darzalex nets approval for self-administered cancer injection” was originally created and published by Pharmaceutical Technology, a GlobalData-owned brand.
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