US FDA approves Johnson & Johnson's blood cancer therapy
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[August 11, 2023]
By Mariam Sunny
(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 based on a patient's weight,
prescribed dosing and treatment duration.
J&J estimates a pricing range of $270,000 to $360,000 for an average
treatment duration of six to eight months.
The company expects to make the therapy available to patients within
three weeks.
Talvey was approved as a weekly or biweekly injection given
under-the-skin to treat patients with relapsed multiple myeloma who have
received at least four prior lines of treatment.
While the FDA approved J&J's Tecvayli, another bispecific antibody, last
year, Talvey is the first of its kind to target a protein known as
GPRC5D, which is mainly present in cancerous plasma cells.
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Signage is seen outside of the Food and
Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.,
August 29, 2020. REUTERS/Andrew Kelly
Around 35,730 people in the U.S. are
expected to be diagnosed with multiple myeloma this year. The cancer
starts in the bone marrow and disrupts production of normal blood
cells.
"Although options for the treatment ... have expanded significantly
in recent years, the disease remains incurable, and therefore,
patients are in need of new treatment options," said Michael
Andreini, CEO of the non-profit Multiple Myeloma Research
Foundation.
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 accelerated approval is based on mid-stage trial data, which
showed 73.6% patients achieved either partial or complete
disappearance of cancer from their body.
(Reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra
Eluri and Maju Samuel)
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