Fierce Pharma May 16, 2024
The FDA has broadened the use of Bristol Myers Squibb’s CAR-T therapy Breyanzi to another type of blood cancer.
Breyanzi has won an accelerated approval to treat patients with relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy.
Wednesday’s nod came about three years after Gilead Sciences’ Yescarta became the first CD19-targeted CAR-T therapy to enter FL. Novartis’ Kymriah followed about a year later with the same third-line nod. All three meds secured accelerated approvals based on tumor shrinkage data.
BMS’ Breyanzi won over the FDA thanks to results from the phase 2 TRANSCEND FL trial. The drug’s current label shows a tumor response rate of 95.7% for patients who received the CAR-T therapy, including...
Today's Sponsors
Today's Sponsor