Michael Andreini News Today

The FDA granted an accelerated approval for Talvey to treat patients with relapsed/refractory multiple myeloma.

/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted...

(Reuters) -Johnson & Johnson said on Thursday the U.S. Food and Drug Administration had approved its antibody-based therapy for patients with a difficult-to-treat type of blood cancer. The therapy, Talvey, belongs to a class of treatments called bispecific antibodies designed to bring a cancer cell and an immune cell together so the body's immune system can kill the cancer. Talvey will be sold at a list price of $45,000 per month, the company told Reuters, adding the price could vary ba...

Talquetamab-tgvs (Talvey) is a first-in-class bispecific antibody that binds to GPRC5D and CD3 to induce T cell-mediated killing of GPRC5D-expressing multiple myeloma cells.

The therapy's approval comes with FDA's "boxed" safety warning, flagging the risk of a type of aggressive immune response and neurologic toxicity.

The therapy’s approval comes with FDA’s “boxed” safety warning, flagging the risk of a type of aggressive immune response and neurologic toxicity.

The approval follows a series of market withdrawals for other multiple myeloma drugs that initially received accelerated FDA approval.

A group of 11 hikers will embark on this incredible challenge to raise awareness and funds for multiple myeloma research through the Multiple Myeloma Research Foundation (MMRF) As part of the Moving Mountains for

Teclistamab is now an option after progression on triple-class therapy; however, the FDA also issued a Boxed Warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity.

Mt. Washington MM4MM hikers take on the challenging climb in July to increase awareness and fundraise for multiple myeloma research...