March 13 (Reuters) - The U.S. Food and Drug
Administration's staff reviewers on Wednesday raised safety
concerns over the use of Johnson & Johnson's ( JNJ ) and Bristol
Myers Squibb's ( BMY ) cancer therapies as earlier treatments
for blood cancer patients.
Staff reviewers said that the pattern of early deaths
observed in patients treated with both the therapies in their
respective trials raised uncertainty about the treatments'
overall survival benefit in patients.
The therapies - J&J's Carvykti and Bristol Myers' Abecma -
are approved by the FDA to treat patients with multiple myeloma
who have received at least four prior lines of treatment.
The FDA staff said that data for J&J's Carvykti was unclear
to establish a favorable benefit-risk profile of the treatment.
Data analysis provided by Bristol Myers did not provide
"convincing evidence" that treatment with Abecma helps patients
extend the time they live after receiving treatment or a benefit
of overall survival.
The comments were made in briefing documents prepared ahead
of a meeting of the FDA's independent advisers on Friday, which
is being closely watched by investors to understand the
regulator's view on CAR-T therapies after recent scrutiny into
the treatments.