NEW BRUNSWICK, NJ – New Jersey based Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has given approval for its antibody-based therapy aimed at treating a challenging type of blood cancer.
Named talquetamab-tgvs and branded as Talvey, this therapy is classified as a bispecific antibody treatment. Such treatments are designed to bring together cancer cells and immune cells, enabling the body’s immune system to eliminate cancer.
Talvey has been granted approval for use as a weekly or biweekly subcutaneous (under-the-skin) injection. It is intended for patients suffering from relapsed multiple myeloma who have previously undergone at least four rounds of treatment.
Multiple myeloma is a type of cancer that originates in the bone marrow and interferes with the production of normal blood cells.
Additional treatment options available for multiple myeloma encompass J&J’s Carvykti and Bristol-Myers Squibb’s Abecma, which belong to the category of CAR-T therapies (chimeric antigen receptor T-cell therapies). These therapies involve extracting a patient’s own T-cells (disease-fighting cells), genetically modifying them to target specific proteins on cancer cells, and then reintroducing them to the body to locate and attack cancer.
Michael Andreini, CEO of the non-profit Multiple Myeloma Research Foundation, noted that while treatment options for multiple myeloma have expanded, the disease remains incurable, emphasizing the need for novel treatment choices.
The FDA has included a prominent “boxed” safety warning on the drug’s label, highlighting the potential risk of aggressive immune responses, cytokine release syndrome, and neurologic toxicity.
The accelerated approval was granted based on data from a mid-stage study, demonstrating that 73.6% of patients achieved either partial or complete reduction of cancer within their bodies.