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USFDA approved Bristol Myers’ Breyanzi to treat newly relapsed or refractory large B-cell lymphoma (LBCL) on Friday. This approval comes nearly three months after Gilead Sciences’ Yescarta became the first CAR-T drug to enter the second-line setting and a little over a year after Breyanzi’s original go-ahead as third-line therapy.

According to Bristol Myers, Breyanzi has an advantage in covering “the broadest patient eligibility” for primary refractory or relapsed LBCL. Meanwhile, Gilead’s Yescarta is indicated for patients who relapse quickly within 12 months. Now, Breyanzi’s new approval covers that patient population and includes a specific line about patients who aren’t considered candidates for stem cell transplants, as per reports.

During the phase 3 Transform trial, Breyanzi cut the risk of event-free survival by 65.1 percent compared with standard chemotherapy followed by stem cell transplant. Patients on Breyanzi lived median of 10.1 months without disease progression or the need for further treatment as compared to 2.3 months for the control group.

However, Yescarta registered a 60.2 percent reduction on a similar event-free survival measurement in its own phase 3 trial dubbed Zuma-7.

Meanwhile, the FDA sweetened the deal for Breyanzi by carving out patients who aren’t considered candidates for stem cell transplants and loosening the eligibility requirement. There, Breyanzi is allowed for patients with refractory disease or who relapse after frontline treatment, regardless of time to relapse.

The broader label comes as a bit of a surprise given BMS only mentioned the Transform trial when Breyanzi nabbed an FDA priority review in February.

Both Yescarta’s Zuma-7 and Breyanzi’s Transform enrolled patients who were fit for stem cell transplant. But BMS apparently added to its application results from the phase 2 Pilot study conducted in transplant-ineligible patients. The company just made the data public a few days ago at the 2022 American Society of Clinical Oncology annual meeting.

It is noteworthy that Yescarta’s second-line DLBCL use has already been added to the National Comprehensive Cancer Network’s guidelines with a category 1—the highest—recommendation. However, Breyanzi will have to wait as the Transform results haven’t been published in a peer-reviewed journal.

Reportedly, the second-line LBCL use is expected to significantly boost demand for Breyanzi.





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