J&J's Darzalex makes FDA history with another myeloma nod in new patients

Johnson & Johnson’s multiple myeloma drug Darzalex has another FDA nod in previously untreated patients under its belt—and this one is a first for a biologic.

The FDA has approved Darzalex in combination with Takeda’s Velcade, thalidomide and dexamethasone (VTd) for new patients who are eligible for stem cell transplant, making it the first biologic regimen for this patient population. Darzalex’s previous two frontline myeloma nods are both in those who are ineligible for transplant.

The green light comes on the back of phase 3 data showing that adding Darzalex to VTd could cut the risk of disease progression or death by 53% compared to VTd alone at a median follow-up of 18.8 months.

Usually, transplant is considered for younger, more medically fit myeloma patients. With the new Darzalex data—and now an FDA stamp of approval—these transplant-eligible patients could have an increased chance at initial response with a biologic treatment option, according to Craig Tendler, J&J’s vice president of oncology clinical development and global medical affairs.

RELATED: J&J's Darzalex pads blockbuster sales with another myeloma nod in new patients

Darzalex made history in the frontline setting in May 2018 when its combo with Velcade and prednisone became the first antibody to rack up an FDA approval in newly diagnosed myeloma patients. Then, in June, it added a second firstline clearance as part of a regimen with Celgene’s Revlimid and dexamethasone in those who’re ineligible for transplants. That combo showed a 44% reduction in the risk of progression or death as opposed to Revlimid plus the corticosteroid.

Evidence supporting the use of the CD38 antibody just keeps building. Just a few days ago, Amgen showed that adding Darzalex to its proteasome inhibitor Kyprolis—a direct rival to Takeda’s Velcade and follow-up Ninlaro—and dexamethasone could cut the risk of disease progression or death by 37%. And in June, J&J offered up positive results from the Columba trial that showed a subcutaneous, more convenient formulation of Darzalex could match the infused version in terms of efficacy.

Thanks to all those new nods and a growing body of efficacy evidence, Darzalex has become a cash cow for J&J’s oncology franchise. Its second-quarter sales jumped 51.6% to reach $774 million.

Still, Darzalex has at least one more monster to slay. As Credit Suisse analyst Vamil Divan noted to investors in June, a regimen containing Velcade, Revlimid and dexamethasone—known as VRd—is the more traditional induction regimen in the U.S., and Darzalex is looking to top it in the ongoing Perseus trial. As Divan figured, though, the J&J drug's VTd win bodes well for positive results from that trial.

RELATED: FDA accepts BLA filing for Sanofi's rival to J&J's Darzalex 

And the drug could have some company soon. The FDA accepted a filing for Sanofi’s anti-CD38 candidate isatuximab in relapsed/refractory myeloma after the French drugmaker's combo with Celgene's Pomalyst and dexamethasone posted a 40% reduction in the risk of disease progression. It could be a legitimate rival to Darzalex, thanks to its shorter infusion time and lower rate of infusion-related reactions. The FDA has set a decision date for the Sanofi therapy of April 30.