Johnson & Johnson on Tuesday announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma. These patients had previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody.
Multiple myeloma is a type of cancer that forms in a type of white blood cell called a plasma cell. In this disorder, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells.
“TECVAYLI is a first-in-class, bispecific T-cell engager antibody that is administered as a subcutaneous treatment.1 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 (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells,” the company said in a statement on Tuesday.
According to the company, this indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s), the company claimed.
TECVAYLI is Janssen’s fourth approved treatment for multiple myeloma and this further diversifies the company’s industry-leading oncology portfolio and deepens its commitment to discovering and developing therapies for this rare blood cancer, the company claims.
“We are greatly encouraged by the FDA’s approval of teclistamab and Janssen’s commitment to the multiple myeloma community. 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,” said Michael Andreini, President and CEO of the Multiple Myeloma Research Foundation in a statement.
During the clinical trial, patients who had received a median of five prior lines of therapy were participants.
“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. The approval of TECVAYLI, which demonstrated an overall response rate of more than 60 percent in heavily pretreated patients, underscores our commitment to translate science into medicines as we strive toward our goal of one day eliminating this disease,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC in a statement.
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