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J&J wins another label expansion for Darzalex in Europe

Multiple myeloma treatment indicated for early use

J&J logo building

Johnson & Johnson, through its Janssen pharmaceutical division, has scored another label expansion in Europe for Darzalex in newly diagnosed multiple myeloma patients. 

This time round, the newly approved formulation is comprised of anti-CD38 Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd), a triple regimen which is commonly used in the treatment of multiple myeloma.

The European Commission has granted a marketing authorisation for the Darzalex-VTd combination as a treatment of newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). J&J was granted FDA approval for this Darzalex regimen last September, in the same patient population.

The new expansion authorisation was based on results from J&J’s phase 3 CASSIOPEIA trial, in which Darzalex and VTd significantly improved progression-free survival by 93% compared to 85% of those treated with VTd alone.

“We asked ourselves can we improve the standard of care that is bortezomib, thalidomide and dexamethasone (VTd) to provide patients with valuable extra time?” said Philippe Moreau, principal investigator and head of the haematology department at the University Hospital of Nantes, France.

“The CASSIOPEIA study answered that question definitively, demonstrating that the addition of daratumumab in combination with VTd can lead to very deep remissions and also prolong PFS,” he added.

The drug, which was originally developed by Danish biotech Genmab, is a monoclonal antibody (mAb) that targets the CD38 protein, which is highly expressed on multiple myeloma cells.

J&J has largely had the anti-CD38 category to itself since Darzalex was first approved in 2015, and has chalked up a number of label expansions during that time, importantly in the early stages of the disease.

This includes another combination regimen, with Celegene’s Revlimid (lenalidomide) and dexamethasone (DRd), for the treatment of newly diagnosed multiple myeloma patients who are ineligible for ASCT.

“This approval represents our commitment to investigate daratumumab in earlier disease stages of multiple myeloma and to develop more effective frontline treatment options for newly diagnosed patients who are eligible for transplantation,” said Craig Tendler, vice president, clinical development and global medical affairs, oncology, Janssen Research & Development.

However, J&J could see its exclusivity disappear as Sanofi’s rival anti-CD38 mAb isatuximab is currently being reviewed by the FDA for the treatment of relapsed/refractory multiple myeloma – with a target action date for a decision due on 30 April.

J&J’s expansion into the earlier settings will see it retain a large share of the market, but the encroachment of another therapy could still damage sales of the blockbuster therapy.

Article by
Lucy Parsons

21st January 2020

From: Regulatory



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