Dive Brief:

• The Food and Drug Administration has conditionally approved a new medicine for multiple myeloma, offering patients with hard-to-treat forms of the blood cancer another therapy option.

• The medicine, which was developed by Johnson & Johnson and will be sold under the brand name Talvey, is what’s known as a bispecific antibody. A first of its kind, Talvey binds to both “CD3,” a protein found on T cells, and “GPRC5D,” a protein found on malignant blood plasma cells, bringing the two together so the immune system has a better shot at identifying and fighting cancer.

• The FDA based its decision on a clinical trial that enrolled multiple myeloma patients whose disease persisted after at least four other therapies. The trial found just under three-quarters of participants responded in some way to J&J’s drug, with roughly a third going into remission. Regulators have requested additional testing to confirm the benefits of Talvey and to keep it on the market.

Dive Insight:

Talvey is J&J’s second bispecific antibody to win approval in multiple myeloma. The first, Tecvayli, was greenlighted last fall.

Tecvayli also goes after CD3; but unlike Talvey, the second protein it binds to is “BCMA” — a popular target among cancer drug developers. AbbVie, Regeneron, Roche and Pfizer are just some of the other companies with multiple myeloma programs designed around BCMA.

J&J, though, is the only one to have FDA-approved bispecifics in this setting. The pharmaceutical giant now has five marketed medicines for multiple myeloma, a list that includes the CAR-T cell therapy Carvykti and the blockbuster antibody drug Darzalex.

In its most recent earnings report, J&J recorded $13.7 billion in pharmaceutical sales from April through June, a 3% increase year over year that was largely driven by the company’s cancer drugs. Sales of Darzalex grew 22%, while those for Carvykti, which is still new to market, were almost five times higher than one year ago, at $117 million.

J&J’s CEO Joaquin Duato, detailing the earnings on a call late last month, called the company’s portfolio of multiple myeloma drugs its “number one growth driver.”

According to Louise Chen, an analyst at the investment firm Cantor Fitzgerald, J&J at the end of 2021 estimated that peak annual sales of Carvykti could exceed $5 billion. The company also classified Tecvayli and Talvey as potential billion-dollar products.

The Talvey approval “demonstrates our commitment to expanding our portfolio of medicines to help address unmet needs for patients who continue to face challenges with this complex hematologic malignancy,” said Peter Lebowitz, global head of oncology for J&J’s Janssen research and development division, in a statement.

Per FDA requirements, Talvey will only be available through a restricted program meant to closely watch for safety concerns. The drug’s labeling contains a boxed warning for neurological toxicities as well as an immune system reaction called cytokine release syndrome. Additionally, it has warnings and precautions related to weight loss, infections and toxicities of the skin, mouth, liver and embryos.

J&J is also evaluating the pairing of Talvey with Tecvayli. Recent results from an early-stage clinical trial showed the combination reduced or eliminated cancerous cells in 84% of participants, who all had multiple myeloma that progressed after prior treatment.