J&J made a new EU regulatory submission for its multiple myeloma monoclonal antibody therapy darzalex. Credit: Michael Vi via Shutterstock.

Johnson and Johnson (J&J) has announced the submission of a type II variation application to the European Medicines Agency (EMA) for its Darzalex (daratumumab)-based quadruplet therapy for multiple myeloma.

The company is aiming for the approval of the Darzalex subcutaneous formulation combined with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).

A type II variation application is submitted when a company is seeking approval for a marketing authorisation that may have a major impact on the safety, quality or efficacy of a medicine, but no change is made to the active pharmaceutical ingredient, the strength of the drug or the route of administration.

In the EU, regulators previously approved the Darzalex combination for patients with newly diagnosed multiple myeloma and light chain (AL) amyloidosis, a blood disease that causes a buildup of amyloids in tissues and organs. Across the EU, it was estimated that over 35,000 individuals were diagnosed with multiple myeloma in 2022, with more than 22,700 patient deaths related to the condition.

The latest regulatory submission is based on positive data from the Phase III PERSEUS trial (NCT03710603). The Phase III study, conducted in partnership with the European Myeloma Network, demonstrated a clinically meaningful reduction in the risk of disease progression or death at a median follow-up of 47.5 months, compared to the control group.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

See Also:

J&J presented data from the study at the 2023 American Society of Hematology (ASH) Annual Meeting, later publishing it in the New England Journal of Medicine.

Darzalex is a CD38-directed monoclonal antibody therapy that treats multiple myeloma by inhibiting tumour cell growth and causing myeloma cell death. Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow and is associated with symptoms such as persistent bone pain, continuous fatigue and repeated infection.

In 2024, the EMA has already been active in advancing multiple myeloma therapies, with positive recommendations for XNK Therapeutic’s cell therapy Evencaleucel and Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel).

In a 6 March press release, Dr Craig Tendler, J&J’s vice president of clinical development, diagnostics, and global medical affairs said: “The impressive results from the PERSEUS study highlight the potential of this daratumumab subcutaneous-based regimen to transform patient outcomes and provide an effective therapy option in newly diagnosed, transplant-eligible multiple myeloma.”