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J&J expands Darzalex use with another first-line FDA approval

Could help defend myeloma franchise against rival Sanofi


Johnson & Johnson’s multiple myeloma therapy Darzalex has received another approval, this time as a combination therapy in the first-line setting. 

Darzalex (daratumumab) has been indicated in combination with bortezomib, thalidomide and dexamethasone (VTD), a triple regimen which is commonly used in the treatment of multiple myeloma. It is approved for newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT).

The approval is based on results from the phase 3 CASSIOPEIA trial, which demonstrated that Darzalex in combination with VTD before or after ASCT resulted in deeper responses. It also improved the progression-free survival rate in patients compared to the use of VTD alone.

“The Darzalex clinical development programme has led to many important firsts, but more importantly, it has generated key insights and understanding into the biology and treatment of multiple myeloma,” said Craig Tendler, vice president, clinical development and global medical affairs, oncology, Janssen Research & Development.

“Today’s milestone marks the seventh FDA approval in less than four years for Darzalex, and the third for newly diagnosed patients,” he added.

The continued expansion of Darzalex signals J&J's continued efforts to fend off competition from rival Sanofi’s isatuximab.

Darzalex has had the anti-CD38 category to itself since 2015, but could face competition from Sanofi soon as the FDA has begun its review of isatuximab in relapsed/refractory multiple myeloma. The expected action date is 30 April 2020.

However, J&J has also filed a follow-up to Darzalex, that could make dosing easier for patients and help to defend its franchise against Sanofi’s isatuximab. The new subcutaneous formulation can be delivered in just a few minutes, whereas the current intravenous infusion of Darzalex takes several hours.

The antibody was originally developed by Danish biotech Genmab – earlier this year J&J took an option on a follow-up drug, HexaBody-CD38, which the partners have said could work in Darzalex failures and in additional indications.

J&J recorded worldwide net sales of $774m for Darzalex in the second quarter of this year, a 51% increase that shows the drug is not slowing down four years after its initial approval in relapsed/refractory myeloma.

Article by
Lucy Parsons

27th September 2019

From: Regulatory



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