Johnson & Johnson, looking to safeguard Darzalex share, eyes subcutaneous label boost

Looking to match Darzalex's indications in multiple myeloma, J&J will submit recent phase 3 data on its subcutaneous FasPro formulation to health authorities. (Hailshadow/GettyImages)

With competition to Johnson & Johnson's intravenous Darzalex mounting, the drugmaker is hustling to convert patients to its subcutaneous version of the drug, Darzalex Faspro. Now, a triumph in the clinic has armed the drugmaker with data that should convince regulators to clear Faspro in another indication—widening its edge over a Sanofi rival.

In a phase 3 trial of relapsed or refractory multiple myeloma patients who had failed on two prior treatments, FasPro, in combination with Celgene's Pomalyst and the steroid dexamethasone, beat out a Pomalyst-dexamethasone (Pd) pairing at staving off cancer progression in adults, partner Genmab said.

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The 304-subject study—dubbed Apollo—tested the FasPro cocktail versus Pd alone in multiple myeloma patients previously treated with Celgene's Revlimid (lenalidomide) plus a proteasome inhibitor, such as Takeda's Velcade and Ninlaro or Amgen's Kyprolis. 

Full trial results are under wraps at the moment, but J&J will be sharing them with health authorities in hopes of expanding FasPro's label. It currently bears four of the original Darzalex's indications, but the more it can rack up, the more market share it can preserve as newcomer Sarclisa from Sanofi gains steam.

The French drugmaker's answer to Darzalex in March scored a thumbs up in patients with relapsed refractory multiple myeloma who'd received two prior therapies, and since then the company's R&D chief, John Reed, M.D., Ph.D., has said the drug has the potential to become the anti-CD38 contender of choice for multiple myeloma treatment. 

But like Darzalex, Sarclisa is an infusion—meaning J&J holds a convenience advantage with Darzalex Faspro. Administration of the rapid Darzalex alternative takes between three and five minutes—a far cry from the hours-long infusion process—freeing up resources at treatment centers and dramatically reducing the amount of time patients spend in treatment, a particular benefit during the COVID-19 pandemic.

RELATED: Sanofi's Sarclisa, chasing Darzalex, brings the heat with big myeloma combo win

Meanwhile, multiple myeloma isn't the only field where J&J is gunning for FasPro market share. In phase 3 results turned out in June, FasPro—combined with a trio of chemo drug cyclophosphamide, dexamethasone and Takeda's Velcade—cleared light chain (AL) amyloidosis in 53% of patients; as of now, there are no FDA approved therapies for the deadly blood disorder, but J&J is hoping Darzalex FasPro will be the first.