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FDA clears first-line use for J&J's Darzalex

Front-line approval a milestone for blockbuster-tipped myeloma drug


Johnson & Johnson’s efforts to position Darzalex earlier in the treatment pathway for multiple myeloma have resulted in a coveted FDA approval for first-line use.

The company’s Janssen unit says Darzalex (daratumumab) has been given the nod for use alongside Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) for newly-diagnosed myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant (ASCT), a key front-line treatment strategy.

The approval is based on the results of the ALCYONE clinical trial presented at the American Society of Haematology (ASH) meeting last December which showed that adding Darzalex to VMP cut the risk of disease progression or death by 50% in these patients.

Darzalex is already one of J&J’s best-performing products, growing 64% in the first quarter of the year to reach $432m, thanks largely to uptake of the drug as a second-line therapy where J&J is currently claiming a 24% share of new prescriptions in the US after getting approval from the FDA in November 2016, according to head of pharma Joaquin Duato.

He told analysts on J&J’s first-quarter results call that first-line use will be the next growth driver for the intravenous anti-CD38 monoclonal antibody, initially based on the comparison with VMP. Later on, additional studies of Darzalex as an add-on to regimens based on Celgene’s Revlimid (lenalidomide) and in ASCT-eligible patients could further expand the opportunity in previously-untreated patients, he added.

J&J is also carrying out mid-stage testing of Darzalex even further up the treatment chain in ‘smouldering’ multiple myeloma, which is a precursor to full-blown disease that can be diagnosed by measuring biomarkers in blood and urine. Meanwhile, to make the product more user-friendly the company has four ongoing phase III trials of a new subcutaneous formulation that should be ready for filing “before 2021”, according to Duato.

J&J licensed Darzalex from Danish biotech Genmab in 2012. Commenting on the latest approval, Genmab chief executive Jan van de Winkel said Darzalex has become the first antibody therapeutic to be approved for patients with newly diagnosed multiple myeloma and provides “an additional treatment option to patients.”

Market research firm Persistence reckons Darzalex and another therapeutic antibody – Roche’s Empliciti (elotuzumab) – which “will not only provide a new treatment option for multiple myeloma patients, but they will also lengthen the time between relapses.”

Article by
Phil Taylor

8th May 2018

From: Regulatory



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