Dive Brief:

• The Food and Drug Administration has approved a regimen involving Johnson & Johnson’s antibody drugs Tecvayli and Darzalex for relapsed multiple myeloma less than three months after the drugmaker presented study data suggesting the combination could have curative potential.   
• The regulator reviewed the drug under its new “national priority voucher” program, which it used “proactively” following J&J’s release of the findings at the American Society of Hematology meeting. The approval issued Thursday was the third under that program, following that of an older antibiotic and a lung cancer treatment from Boehringer Ingelheim. The review took a total of 55 days, according to the FDA.
• The decision also converts Tecvayli’s authorization from a conditional, “accelerated” approval to full clearance that’s based on its ability to improve survival in early disease.

Dive Insight:

In multiple myeloma, an influx of treatments have arrived in recent years that target BCMA, a protein found on diseased white blood cells. Some, like Bristol Myers Squibb’s Abecma and J&J and Legend Biotech’s Carvykti, are engineered cell therapies. Another, GSK’s Blenrep, is an antibody-drug conjugate.

Tecvayli, by comparison, is a “bispecific” antibody that binds to BCMA on diseased cells and a protein on immune cells. It’s one of several “T cell engagers” now available to treat myeloma. And it’s also now the only one to win a full approval and move beyond late-line settings, giving J&J a leg up over multiple rivals.

The data supporting Tecvayli’s approval with Darzalex were termed “remarkable” by one study investigator. The combination was compared with two commonly used standard of care drug regimens using Darzalex as a backbone in those who had progressed or didn’t respond to one to three treatment lines.

The Tecvayli-Darzalex combination reduced the relative risk of progression or death by 83%. Among those alive and relapse-free at six months, 90% had still avoided cancer progression three years after the study’s start, indicating the combination might have curative potential.

Cell therapies like Carvkyti offer the chance of a similarly deep and durable benefit. But unlike bispecific drugs, they’re usually administered in specialized facilities able to monitor patients for severe immune-related side effects following treatment.

Drugmakers hope T cell engagers open up treatment to more people who live further away from these specialized centers, even though they can also stimulate the same worrisome immune reactions. Some hospitals are trying to navigate those risks by giving patients symptom monitoring tools and other drugs that can tamp down the immune response.