FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma

The FDA has approved the supplemental biologics license application (sBLA) for Johnson & Johnson’s Tecvayli (teclistamab-cqyv) for a reduced dosing frequency every two weeks in patients with relapsed or refractory multiple myeloma (RRMM). This dosing regimen would be for patients who have achieved and maintained a complete response or better for a minimum of six months.

Tecvayli was granted accelerated approval in October 2022 to treat adult patients with relapsed or refractory multiple myeloma who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.

“The approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules,” Rachel Kobos, M.D., vice president, Oncology Research & Development, Johnson & Johnson Innovative Medicine, said in a press release.

Tecvayli is a bispecific T-cell engager antibody to treat patients who have previously received four or more prior lines of therapy. A bispecific antibody can bind to two different targets on two different cells at the same time. Tecvayli is an off-the-shelf therapy that targets the CD3 receptor expressed on the surface of T-cells and the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells.

When Tecvayli launched in November 2022, Tecvayli had a list price of $39,500 per month, based on the original dosing schedule. Eligible patients with commercial insurance can $5 per dose, with a yearly $26,000 maximum benefit, through the Janssen CarePath Savings program.

The new approval is based on data from the phase 1/2 MajesTEC-1 study. Patients were initially treated with 1.5 mg/kg Tecvayli weekly administered subcutaneously. Patients who achieved a confirmed complete response or better for six months or longer (phase 2) were eligible to reduce dosing frequency to 1.5 mg/kg weekly disease progression or unacceptable toxicity.

As of January 2023, 165 patients had received Tecvayli weekly. Of 104 responders, 63 patients switched to every other week dosing and 9 patients nine patients were able to be switched to receiving Tecvayli every four weeks. At a median follow-up of 12.6 months after switching, 68.7% of patients remained in response for two or more years from the time of first response. As of data cut-off, 42 of 63 responders maintained a response after switching to less frequent dosing. The new onset of grade 3 or higher infections was lower in responders who switched to biweekly doses or every four week dosing compared with those who remained on weekly dosing. These data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2023.