By Bhanvi Satija and Sneha S K
March 15 (Reuters) - Advisers to the U.S. health
regulator voted in favor of allowing the use of Johnson &
Johnson and Bristol Myers Squibb's cell
therapies as earlier treatments on Friday, paving the way for
their use in less severely affected patients with a type of
blood cancer.
While all 11 voting members of the panel unanimously agreed
the benefits of J&J and Legend Biotech's ( LEGN ) Carvykti
outweighed the risks of the therapy when given as an earlier
treatment, only eight voted in favor of Bristol's Abecma.
The therapies are already approved in the U.S. for multiple
myeloma patients whose cancer has returned or stopped responding
to four prior lines of 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 panelist Mary Kwok.
The FDA's staff reviewers presented concerns about a pattern
of early deaths observed in late-stage studies of both the
therapies, which they had raised earlier this week.
Bristol, which partners with 2seventybio for
Abecma, said the deaths occurred in patients before receiving
its therapy and most were due to patients' disease worsening.
Panelists noted the time patients live after receiving
Abecma was relatively similar to those who received
standard-of-care therapy in the trial.
"The data we have now appears transient and there's no clear
benefit that earlier is better than later," said panelist Daniel
Spratt who voted against early use of Abecma.
For Carvykti, several panelists said that while the early
deaths were concerning, their cause was not immediately clear
and it seemed unlikely they were related to the therapy.
J&J said some of the early deaths occurred at a time when
patients were receiving therapy that would have helped them
bridge to Carvykti.
The FDA, which usually follows the advice of its panel but
is not bound to do so, is expected to make a decision on early
use of Carvykti by April 5.