J&J seeks approval in EU of Tecvayli-Darzalex for hard-to-treat myeloma
Combo therapy also under review in US, Brazil for already-treated patients
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Johnson & Johnson is now seeking regulatory approval in the European Union for Tecvayli (teclistamab) plus Darzalex Faspro (daratumumab and hyaluronidase-fihj) for individuals with previously-treated multiple myeloma.
The company has submitted an application to the European Medicines Agency (EMA) to allow the combo’s use as a second-line treatment.
Specifically, the application seeks approval of Tecvayli-Darzalex in adults with myeloma that is refractory — resistant to treatment — or relapsed, meaning it’s come back after initially responding to treatment, following at least one previous line of therapy.
“Johnson & Johnson is committed to redefining what’s possible in multiple myeloma,” Jordan Schecter, MD, vice president, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, said in a company press release announcing the filing.
“An integral part of this strategy involves using the right medicines as early as possible and combining and sequencing them to achieve the best outcomes. Today’s submission to the EMA reinforces this approach,” Schecter said.
The filing in the EU follows similar applications seeking approval of the combination therapy in the U.S. and Brazil, submitted late last year.
MajesTEC-3 trial data support Tecvayli-Darzalex applications
These applications were all supported by data from a Phase 3 clinical trial, dubbed MajesTEC-3 (NCT05083169), that evaluated a combination of Tecvayli and Darzalex Faspro in 587 individuals who had received one to three prior treatments for their cancer.
Darzalex Faspro — branded in Europe as Darzalex subcutaneous formulation — is an under-the-skin injection therapy that targets CD38, a protein expressed by myeloma cells. Tecvayli, meanwhile, is designed to induce the immune system to attack myeloma cells by simultaneously binding a myeloma protein called BCMA and an immune cell protein called CD3.
The therapies together were tested in MajesTEC-3 against other Darzalex Faspro combination regimens that are currently considered standard-of-care for second-line relapsed/refractory multiple myeloma.
There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved.
After a median follow-up of three years, 83.4% of patients given the Tecvayli regimen were alive and free from disease progression, compared with less than 30% of patients given standard care.
“There remains a critical need for off-the-shelf treatment options that can achieve deep and durable responses at second line, when immune function is better preserved,” said Ester in ’t Groen, Europe, the Middle East and Africa therapeutic area head for hematology at Johnson & Johnson Innovative Medicine.
The combination of Darzalex Faspro and Tecvayli “is the first off-the-shelf immunotherapy combination to demonstrate significant improvements in progression-free and overall survival in relapsed/refractory multiple myeloma as early as second-line treatment, compared to current standards of care,” in ’t Groen added.
Both therapies are already approved in Europe: Darzalex subcutaneous formulation is authorized as part of various regimens for newly diagnosed and previously treated myeloma, while Tecvayli is approved for use in myeloma patients who have received at least three prior lines of treatment.
According to Schecter, Darzalex has “become a cornerstone of care for patients with newly diagnosed multiple myeloma. … By combining it with [Tecvayli], we see the potential to advance outcomes for relapsed patients as early as second line.”
