FDA News

FDA grants priority review to lisocabtagene maraleucel for advanced B-cell lymphoma

The FDA granted priority review to lisocabtagene maraleucel for the treatment of adults with relapsed or refractory large B-cell lymphoma, according to the agent’s manufacturer.

Lisocabtagene maraleucel (Juno Therapeutics/Bristol-Myers Squibb) is an autologous anti-CD19 chimeric antigen receptor T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells.

The investigational compound contains a CAR construct composed of CD8 and CD4 CAR T cells and includes an anti-CD19 single-chain variable fragment that targets the specific antigen domain, a transmembrane domain, a 4-1BB costimulatory domain and a CD3-zeta T-cell activation domain.

Juno Therapeutics submitted the biologics license application based on safety and efficacy results of the open-label, multicenter phase 1 TRANSCEND-NHL-001 trial presented at last year’s ASH Annual Meeting and Exposition.

The trial included 268 patients with relapsed or refractory large B-cell lymphoma who received lisocabtagene maraleucel at one of three dose levels. Results showed an overall response rate of 73% (95% CI, 67-78), with 53% (95% CI, 47-59) of patients achieving complete response. Treatment responses were similar across all three patient subgroups.

“There remains a critical need for additional therapies in large B-cell lymphoma, particularly for relapsed or refractory patients,” Stanley Frankel, MD, senior vice president of cellular therapy development at Bristol-Myers Squibb, said in a company-issued press release.

“Based on the TRANSCEND-NHL-001 data, [lisocabtagene maraleucel] has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed,” he added. “This biologics license application acceptance and priority review designation is an important step as we work to improve treatment for these patients in need.”

Lisocabtagene maraleucel previously received breakthrough therapy and regenerative medicine advanced therapy designations by the FDA for adults with relapsed or refractory aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma.

The FDA set a target action date for this application of Aug. 17.

The FDA granted priority review to lisocabtagene maraleucel for the treatment of adults with relapsed or refractory large B-cell lymphoma, according to the agent’s manufacturer.

Lisocabtagene maraleucel (Juno Therapeutics/Bristol-Myers Squibb) is an autologous anti-CD19 chimeric antigen receptor T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells.

The investigational compound contains a CAR construct composed of CD8 and CD4 CAR T cells and includes an anti-CD19 single-chain variable fragment that targets the specific antigen domain, a transmembrane domain, a 4-1BB costimulatory domain and a CD3-zeta T-cell activation domain.

Juno Therapeutics submitted the biologics license application based on safety and efficacy results of the open-label, multicenter phase 1 TRANSCEND-NHL-001 trial presented at last year’s ASH Annual Meeting and Exposition.

The trial included 268 patients with relapsed or refractory large B-cell lymphoma who received lisocabtagene maraleucel at one of three dose levels. Results showed an overall response rate of 73% (95% CI, 67-78), with 53% (95% CI, 47-59) of patients achieving complete response. Treatment responses were similar across all three patient subgroups.

“There remains a critical need for additional therapies in large B-cell lymphoma, particularly for relapsed or refractory patients,” Stanley Frankel, MD, senior vice president of cellular therapy development at Bristol-Myers Squibb, said in a company-issued press release.

“Based on the TRANSCEND-NHL-001 data, [lisocabtagene maraleucel] has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed,” he added. “This biologics license application acceptance and priority review designation is an important step as we work to improve treatment for these patients in need.”

Lisocabtagene maraleucel previously received breakthrough therapy and regenerative medicine advanced therapy designations by the FDA for adults with relapsed or refractory aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma.

The FDA set a target action date for this application of Aug. 17.

    See more from Immuno-Oncology Resource Center