J&J scores EU approval for Tecvayli combo in second line

Johnson & Johnson has secured another approval for its multiple myeloma drug Tecvayli (teclistamab), with the European Commission granting approval for the drug in combination with Darzalex (daratumumab) for relapsed/refractory multiple myeloma.

The drug previously had a conditional approval in the EU in 2022, but only for patients who had tried three other lines of therapy. This approval makes the drug available as a second-line therapy. It follows a similar decision by the US FDA in March, which was expedited by the controversial Commissioner's National Priority Voucher programme.

"This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma," Ester in 't Groen, EMEA therapeutic area head for haematology at Johnson & Johnson said in a statement. "By combining the complementary mechanisms of teclistamab, a BCMAxCD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the immune system, we can deliver meaningful long-term outcomes earlier in the treatment journey, where they have the greatest opportunity to influence the disease trajectory and redefine expectations for patients.”

Like the FDA clearance in March, this approval was based on the MajesTEC-3 study reported at last year's ASH congress, which showed significant improvements with the regimen in both progression-free survival (an 83% improvement) and overall survival (a 54% gain) compared to anti-CD38 antibody Darzalex Faspro (daratumumab plus hyaluronidase) and dexamethasone. In addition more than 90% of patients who were progression-free at six months remained so at three years, illustrating the durability of the regimen.

Teclistimab is an off-the-shelf bispecific antibody that redirects T cells to fight myeloma cells. It works in tandem with daratumumab, which modulates the immune system to enhance T cell fitness and activation.

“Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making earlier access to the most effective treatments increasingly important,” Dr María-Victoria Mateos, director of the Myeloma Unit at the University Hospital of Salamanca, Spain, said in a statement. “Today’s approval of teclistamab in combination with daratumumab marks an important advance by providing physicians with an off-the-shelf, steroid-sparing, immunotherapy option that has demonstrated meaningful improvements in progression-free and overall survival, with the potential to redefine treatment expectations as early as second line.”