NEW YORK – Bristol Myers Squibb on Tuesday said the US Food and Drug Administration has accepted two supplemental biologics license applications seeking approval for Breyanzi (lisocabtagene maraleucel) as a treatment for relapsed or refractory follicular lymphoma and mantle cell lymphoma.
Simultaneously, the firm said that Japan's Ministry of Health, Labor, and Welfare has accepted a supplemental new drug application seeking approval for Breyanzi in the same follicular lymphoma indication.
In these applications, BMS submitted data from the TRANSCEND FL and TRANSCEND NHL 001 studies. In the former study, the firm tested Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including those with high-risk follicular lymphoma in their second line of treatment. There was a high rate of complete responses to Breyanzi treatment, the company said.
In the mantle cell lymphoma cohort in the TRANSCEND NHL 001 study, treatment with the cell therapy yielded "statistically significant and clinically meaningful responses in heavily pretreated patients, with the majority of patients achieving a complete response," BMS said in a statement.
"Patients living with follicular lymphoma and mantle cell lymphoma often experience cycles of remission and relapse with multiple lines of treatment, and we are committed to delivering innovative treatment solutions to this population," Anne Kerber, senior VP and head of late clinical development within BMS's hematology, oncology, cell therapy division, said in a statement. "Breyanzi offers the potential for durable response, and these filing acceptances in the US and Japan support our commitment to delivering our best-in-class CAR T-cell therapy treatments to as many eligible patients as possible."
Breyanzi, an autologous CD19-directed CAR T-cell therapy, is already approved in the US for treating patients with large B-cell lymphoma (LBCL), including diffuse LBCL, high-grade B-cell lymphoma, and primary mediastinal LBCL. For follicular lymphoma patients, the treatment is also approved in the US for those with grade 3B disease that is refractory to first-line chemoimmunotherapy, for patients who aren't eligible for hematopoietic stem cell transplant due to comorbidities or age, and for those who have stopped responding after two or more lines of systemic therapy.
The cell therapy is also approved in Japan and Europe as a second-line treatment for relapsed or refractory LBCL, and in Japan, Europe, Switzerland, the UK, and Canada for treating relapsed and refractory LBCL after two or more lines of systemic therapy. If Breyanzi is approved in follicular lymphoma in Japan, that would expand the use of this therapy into an entirely new type of hematologic cancer.
The two sBLAs in the US, if successful, would allow BMS to expand Breyanzi's use to a broader population of relapsed or refractory follicular lymphoma patients, and, for the first time, as a treatment for relapsed or refractory mantle cell lymphoma after patients have received a Bruton tyrosine kinase inhibitor. The FDA has granted both applications priority review and is expected to decide about the follicular lymphoma application by May 23 and about the mantle cell lymphoma application by May 31.