Daratumumab

Johnson & Johnson, which has several drugs approved for multiple myeloma, praised the FDA’s just-released draft guidance on how the agency will allow the use of minimal residual disease as a primary endpoint for accelerated approvals of treatments for the blood cancer. The nine-page draft published Tuesday spells out how drug developers can use MRD as an endpoint in several ways, including via a single-arm trial, with the ongoing trial continuing to evaluate progression-free-survival or overall survival to support a full approval. An FDA advisory committee in 2024 voted unanimously to allow the use of MRD as an endpoint. J&J pioneered much of the evidence behind the use of MRD, EVP John Reed said on Wednesday’s earnings call, “so we’re excited that that is an option.” “We are mindful, however, that it’s only an option in the United States. So we, at this point, will still have to deliver progression-free and overall survival data for other territories,” he said. The FDA’s draft says multiple myeloma makes up about 18% of all blood cancers in the US and that 20 new drugs or biologics have been approved since 2003. That’s helped push overall survival to those newly diagnosed to seven to 10 years, or about twice as long as in the early 2000s. J&J’s second-line multiple myeloma treatment Darzalex brought in more than $14 billion last year, the company reported, while its more recently approved second-line treatment Carvykti became a blockbuster for the first time in 2025. The company’s potential combined treatment of Tecvayli and Darzalex in December also scored a new voucher from the FDA that expedites the combo’s review to one to two months. “Vigilant FDA leaders just saw an impressive multiple myeloma trial result” published ahead of the American Society of Hematology conference in Orlando, FL, Commissioner Marty Makary wrote on X last month. Agency experts conferred and “contacted the company THE NEXT DAY to issue them a national priority voucher.” J&J also said it “will be speaking with the agency about opportunities to accelerate some of our development” in multiple myeloma, following the release of the draft guidance and positive ODAC vote . “And in that regard, I think a place where this could be particularly apropos is with our new trispecific antibody for myeloma,” Reed added. The first clinical data for J&J’s potential trispecific antibody, known as JNJ-5322, showed a 100% overall response rate, according to data published in May.