FDA Approves Talvey to Treat Blood Cancer

The FDA has granted accelerated approval to Talvey (talquetamab-tgvs), a first-in-class bispecific antibody to treat adult patients with relapsed or refractory multiple myeloma. It is indicated for patients who have received at least four prior lines of therapy. Developed by Janssen Pharmaceutical Company, Talvey is a weekly or biweekly subcutaneous (SC) injection after an initial step-up phase.

Multiple myeloma is an incurable blood cancer that affects plasma cells, which are found in the bone marrow. In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the United States. People with multiple myeloma have a five-year relative survival rate of 59.8%.

Talvey is a bispecific antibody that targets both CD3 receptor on T cells and GPRC5D. CD3 is involved in activating T cells, and GPRC5D is overexpressed on multiple myeloma cells. It will be available in the next few weeks and will have a price of $45,000 per month, for a range of $270,000 to $360,000, based on the typical average treatment duration of six to eight months in the clinical trial, according to a Janssen spokesperson. The company expects that Talvey will be covered by Medicare and most commercial insurance plans.

Ajai Chari, M.D.

“Patients at this stage of disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer,” Ajai Chari, M.D., director of Multiple Myeloma Program, professor of Clinical Medicine at the University of California, San Francisco, said in a press release.

The accelerated approval was supported by data from the phase 2 MonumenTAL-1 study, which showed meaningful overall response rates (ORR) in 73.6% of patients. With a median follow-up of nearly six months from first response among responders, 58% of patients achieved a very good partial response or better, including 33% of patients achieving a complete response. An estimated 85% of responders maintained response for at least nine months.

Janssen had submitted the biologics license application to the FDA in December 2022.