J&J Gets FDA Greenlight For New Blood Cancer Drug

The Food and Drug Administration (FDA) approved Johnson & Johnson’s new therapy for adults with multiple myeloma, a type of difficult-to-treat blood cancer on Wednesday. 

The drug, called talquetamab-tgvs, which will be branded as Talvey, belongs to a class of treatments called bispecific antibodies. 

The new therapy is the first-of-its-kind medication designed to attract T-cells, a type of immune cell close to the cancer cells, so that the immune system can target a specific protein found on malignant cells and destroy the cancer. 

The FDA approved the medication as a weekly or a bi-weekly injection, noting it’s suitable for patients whose cancer has relapsed or has stopped responding to the treatment and who have previously tried at least four different lines of therapy. 

Talvey is expected to be available for patients within the next three weeks, the drug maker told Reuters. 

The new medication’s unique ability to target a specific protein distinguishes it from Johnson & Johnson’s other bispecific antibody drug for multiple myeloma, teclistamab-cqyv, branded Tecvayli which the FDA also approved last year. It’s also the fifth therapy the company has developed to treat the condition. 

"Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options,” Michael Andreini, president and chief executive officer of Multiple Myeloma Research Foundation, said in a statement.

This year, according to the American Cancer Society (ACS), over 35,000 people are expected to be diagnosed with multiple myeloma, and over 12,000 will likely die from the condition. 

Multiple myeloma is a cancer of plasma cells, which are an important part of the immune system and are found in the bone marrow, according to the ACS. Multiple myeloma occurs when those cells become cancerous and start to grow out of control.

The drug’s accelerated approval was based on the Phase 2 results which found that out of the 187 participants who received a biweekly dose of the medication,  73.6% of them saw a partial or complete disappearance of all signs of cancer. 

Johnsons & Johnson will likely set the retail cost of the drug at $45,000 per month, the company told Reuters. However, the pricing might vary depending on a person’s weight, recommended dosage and treatment duration. 

Furthermore, the company added that the drug’s price could range from $270,000 to $360,000 for an average six to eight-month treatment period. 

It's unclear at this time whether the drug will be covered by insurance, though previous cancer treatments from this drug maker have been covered.
As far as adverse reactions go, the FDA’s “boxed warning” for the drug notes that it could cause an intense immune system reaction called cytokine release syndrome which could be life-threatening or fatal and include symptoms such as fever, nausea, body aches or fatigue.