In multiple myeloma showdown, J&J adds another feather to Darzalex's cap
Sanofi’s Sarclisa burst onto the multiple myeloma scene last year to challenge J&J’s CD38 heavyweight Darzalex. But J&J isn’t going down without a fight, and now it’s touting another approval for the hard-to-treat blood cancer — along with an easier route of administration that could save patients hours of their time.
The FDA has given Darzalex Faspro the thumbs-up as a second-line treatment for adults with multiple myeloma in combination with pomalidomide and dexamethasone (Pd), Janssen said Monday. The approval marks the sixth indication for Darzalex Faspro, which is co-formulated with Halozyme’s recombinant human hyaluronidase PH20, a type of enzyme that catalyzes the degradation of hyaluronic acid.
According to J&J, the drug is now the first subcutaneous CD38 antibody approved in combination with Pd — shaving hours off of the time it would take to deliver it via IV.
“With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration,” principal investigator Meletios Dimopoulos said in a statement.
The approval was based on the APOLLO study, which showed that Darzalex Faspro and Pd reduced patients’ risk of disease progression or death by 37% compared to Pd alone (p=0.0018). Mean progression-free survival in the treatment arm was 12.4 months, compared to 6.9 months in the control arm, J&J said. And 25% of patients on Darzalex Faspro achieved complete responses, compared to just 4% in the Pd arm, according to the pharma.
The treatment does come with some risks, as half of patients experienced a serious adverse event, some of the most common being pneumonia and respiratory tract infection. Fatal side effects occurred in 7% of patients.
J&J inked a $1.1 billion agreement with Genmab to develop, manufacture and commercialize Darzalex back in 2012. It shelled out $55 million upfront, with tiered “double digit” royalties. Last year, the blockbuster raked in about $4.19 billion.
Sarclisa was approved in March 2020 to treat multiple myeloma in combination with pomalidomide and dexamethasone. And earlier this year, it was OK’d for multiple myeloma patients who’ve received one to three lines of therapy in combination with carfilzomib and dexamethasone. Researchers say the cocktail reduced the risk of disease progression or death by 45% compared to standard of care.