J&J receives fifth FDA nod for treating multiple myeloma, with boxed warning and REMS in tow

Johnson & Johnson’s Janssen has received its fifth drug approval for multiple myeloma, securing an accelerated nod for its bispecific Talvey on Thursday morning.

The FDA cleared the antibody, known investigationally as talquetamab, for adults with relapsed or refractory multiple myeloma after four or more prior treatment attempts. Talvey will become available within three weeks, a spokesperson told Endpoints News via email. The list price is $45,000 per month or a range of $270,000 to $360,000, depending on treatment duration. In clinical studies, patients were typically on treatment for about six to eight months, the spokesperson said, noting J&J expects Medicare and most commercial insurance plans to cover Talvey.

The regulatory OK comes as J&J and partner Legend Biotech recently celebrated a better-than-expected second quarter for their blood cancer cell therapy Carvykti, which hit $117 million in sales when analyst consensus was below nine figures. Talvey’s OK adds to an arsenal of multiple myeloma treatment options, including Carvykti and Bristol Myers Squibb’s CAR-T Abecma, among others. GSK meanwhile recently pulled Blenrep after a Phase III flop.

FDA approved Talvey for delivery under the skin once weekly or every other week after a step-up phase. It binds to the CD3 receptor on the T cell’s surface and a specific group of GPCRs known as class C group 5 member D. Known as GPRC5D, it is also targeted by Bristol Myers and OriCell, which said on Thursday it received IND clearance for its CAR-T cell therapy.

“Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options,” Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation, said in a statement.

Mark Wildgust

Patients and their doctors will have to weigh the safety profile of Talvey. The drug’s label comes with a boxed warning for cytokine release syndrome, in which the immune system goes into overdrive, and neurologic toxicity. A “majority of patients” experienced CRS, Mark Wildgust, Janssen’s VP of oncology medical affairs, previously told Endpoints. In addition to the boxed warning, Talvey’s safety profile includes warnings and precautions for oral toxicity, weight loss, infections, cytopenias and various other toxicities.

Doctors must also adhere to a risk evaluation and mitigation strategy when prescribing the medication, as they do for the Big Pharma’s other multiple myeloma bispecific, Tecvayli, which was greenlit last October. J&J has studied a combination of the two drugs, showing an overall response rate of 86.6% across all dose levels in a study presented at this year’s American Society of Clinical Oncology.

The FDA based its decision on Phase II results presented at last December’s American Society of Hematology annual confab, a day after J&J submitted the approval paperwork.

In the Phase II MonumenTAL-1 study used for the regulatory application, J&J reported 73.6% of patients responded to biweekly treatment. On the weekly dose, an almost equal percentage, 73%, of patients responded. Of the responders, about one-third had a complete response or better in both groups.

The median duration of response was 9.5 months for the weekly dosing group, and that measure was not reached in the biweekly cohort.

The trial also included a group of patients who had previously been on another bispecific antibody or CAR-T cell therapy, among additional treatments. In that subset of 32 patients, 72% responded to Talvey.

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