Apr 06,2024
London: The U.S. Food and Drug Administration on Friday allowed the use of cell therapy Abecma from Bristol-Myers Squibb and 2seventybio in less severely affected patients with a type of blood cancer.
The decision comes after a panel of expert advisers voted in favor of Abecma’s use as an earlier treatment for multiple myeloma, a common form of cancer that affects older adults.
The cell therapy is already approved in the U.S. to treat patients with multiple myeloma who have received four or more prior lines of treatment.
The health regulator is also reviewing cancer cell therapy, Carvykti, from Johnson & Johnson and its partner Legend Biotech for use in less severely affected patients. The FDA is set to decide on it by April 5. Abecma and Carvykti belong to a class of treatments known as chimeric antigen receptor (CAR) T-cell therapies that work by modifying white blood cells known as T-cells to attack cancer.
Bristol Myers ‘ application included late-stage data that showed Abecma helped extend the time before disease progression by 13.3 months on average in patients whose cancer has returned or stopped responding to at least two prior treatments.
This compared to 4.4 months progression-free survival seen in trial patients who received standard of care.
Analysts estimate $601 million in sales for Abecma in 2024, according to LSEG data.
The current standard of care includes use of non CAR-T therapies or regimens in less severely affected patients.
Approved medications for the condition include J&J’s Darzalex and generic cancer drugs such as pomalidomide and bortezomib.
Source: Pharma
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