J&J Wins Bi-Weekly Dosing Approval from FDA for Tecvayli in Multiple Myeloma

J&J Switzerland_iStock, yuelan

Pictured: J&J's building in Switzerland/iStock, yuelan

The FDA on Tuesday approved Johnson & Johnson’s supplemental Biologics License Application for its anti-BCMA antibody Tecvayli (teclistamab-cqyv), allowing its use once every two weeks to treat patients with relapsed or refractory multiple myeloma.

The reduced dosing frequency only applies to patients who have achieved and maintained at least complete response (CR) for a minimum of six months, providing them with “increased flexibility” in their medication schedule, according to the pharma’s announcement.

“Today’s 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, vice president for oncology research and development and J&J Innovative Medicine, said in a statement.

The FDA’s approval on Tuesday is based on data from the Phase I/II MajesTEC-1 study, which initially treated patients with the recommended weekly dosing of Tecvayli before transitioning them to a biweekly schedule. Only those who had shown CR for six months or longer were eligible for the reduced dosing schedule.

In June 2023, J&J posted long-term data from MajesTEC-1 demonstrating that Tecvayli could sustain deep responses in patients who had achieved CR, event at less frequent dosing patterns. After a median follow-up of about 12 months after switching to a biweekly schedule, the majority of patients maintained their response to Tecvayli, which also resulted in fewer grade 3 or higher infections after switching.

The biweekly regimen was deemed safe, with no new signals of concern.

Tecvayli is a bispecific T-cell engager antibody that targets the BCMA protein and CD3 receptor, which are both hallmarks of T cell malignancies. The therapy was approved under the FDA’s accelerated pathway in October 2022.

Tuesday’s approval of Tecvayli’s biweekly dosing schedule comes weeks after J&J’s development partner Legend Biotech announced that the FDA has decided to convene its Oncologic Drugs Advisory Committee to assess their bid to use the CAR-T therapy Carvykti (ciltacabtagene autoleucel) in earlier lines of treatment for multiple myeloma. The meeting has yet to be scheduled.

Carvykti is currently indicated for relapsed or refractory multiple myeloma patients who have undergone at least four prior lines of therapy.

Also targeting multiple myeloma is J&J’s Darzalex Faspro (daratumumab and hyaluronidase-fihj), an anti-CD38 therapy first approved in May 2020, which has so far secured eight indications in the blood cancer.

In December 2023, J&J and partner Genmab revealed data from the Phase III Perseus study, demonstrating that a Darzalex Faspro-based quadruplet regimen—including bortezomib, lenalidomide and dexamethasone—significantly improved progression-free survival in transplant-eligible patients with newly diagnosed disease.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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