Bristol Myers Squibb CAR T Cell Therapy Lisocabtagene Maraleucel gets EMA validation

"With more than 30% of patients diagnosed with diffuse large B-cell lymphoma ultimately relapsing after initial therapy and an expected overall survival of about six months for patients who have had two or more prior therapies, there is a need for new treatments," said Stanley Frankel, M.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb.1,2 "The EMA's validation of our application is a critical step toward bringing liso-cel to patients in Europe."

The EMA previously granted liso-cel access to the PRIME scheme for the treatment of R/R DLBCL and, more recently, Accelerated Assessment status, reducing the maximum timeframe to 150 days for the EMA's Committee for Medicinal Products for Human Use (CHMP) to review the application.

Liso-cel is an investigational therapy that is not approved for use in any country.

About TRANSCEND NHL 001

TRANSCEND NHL 001 is an open-label, multicenter, pivotal Phase 1 study to determine the safety, antitumor activity and pharmacokinetics of liso-cel in patients with R/R B-cell NHL, including DLBCL, HGL, PMBCL and Grade 3B FL. Mantle cell lymphoma is investigated in a separate cohort. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Key secondary outcome measures included complete response rate, duration of response and progression-free survival. The TRANSCEND program is a broad clinical program evaluating liso-cel in multiple indications and treatment lines.

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