Janssen has received the green light from the Food and Drug Administration for Tecvayli (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
Tecvayli is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment. This off-the-shelf (or ready-to-use) therapy uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.
Tecvayli is Janssen's fourth approved treatment for multiple myeloma.
"We are greatly encouraged by the FDA's approval of teclistamab and Janssen's commitment to the multiple myeloma community," said Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation. "Multiple myeloma is a life-threatening disease with considerable unmet need, and teclistamab is an important new treatment option for patients who have faced multiple relapses."
"Today's achievement, which marks an important addition to our diverse and growing oncology portfolio, strengthens our resolve to discover and develop much-needed cancer treatments for patients and physicians," said Peter Lebowitz, global therapeutic area head, oncology at Janssen research and development. "The approval of Tecvayli, which demonstrated an overall response rate of more than 60% in heavily pretreated patients, underscores our commitment to translate science into medicines as we strive toward our goal of one day eliminating this disease."
"In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma," said Ajai Chari, professor of medicine, division of hematology and medical oncology at the Icahn School of Medicine at Mount Sinai and study investigator. "As a clinician and researcher, I see first-hand the human toll of this incurable disease. The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many of these hard-to-treat patients."