Advisers to the U.S. health regulator on Friday unanimously voted in favor of allowing the use of Johnson & Johnson's cell therapy as an earlier treatment, paving the way for its use in less severely affected patients with a type of blood cancer.
All eleven voting members of the Food and Drug Administration's (FDA) advisory panel agreed that benefits of J&J's Carvykti outweighed the risks of the therapy when given as an earlier treatment. "To be able to give a one-time treatment (to patients) and without requiring them to come back and forth is a really important option," said panel member Mary Kwok.
The panel will also discuss and vote on the use of Bristol Myers Squibb and partner 2seventybio's therapy Abecma as an earlier treatment later on Friday.
The treatments – Carvykti and Abecma – are already approved in the US for multiple myeloma patients, whose cancer has returned or stopped responding to four prior lines of treatment.
The FDA's staff reviewers presented concerns about a pattern of early deaths observed in Carvykti's late-stage trial, which they had raised earlier this week.
The reviewers said that it was difficult to determine which early deaths occurred due to Carvykti-related toxicity and which occurred due to a delay in receiving Carvykti during the study.
Several panel members said that while the early deaths were concerning, their cause was not immediately clear, but it seemed unlikely that they were related to the therapy.
J&J, which partners with Legend Biotech for Carvykti, said that some of the early deaths occurred at a time when patients were receiving therapy that would have helped them bridge to Carvykti, based on the design of the study.
The regulator, which usually follows the advice of its panel but is not bound to do so, is expected to make a decision on expanding the use of Carvykti by April 5.
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