Regulatory Applications Accepted Across Three Regions Globally for Abecma for Earlier Use in Adults with Triple-Class Exposed R/R Multiple Myeloma
“Our continued focus on bringing Abecma into earlier lines of treatment demonstrates our commitment to increasing treatment options and improving outcomes for patients living with multiple myeloma,” said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. “This FDA acceptance marks another step forward in our mission by bringing us closer to offering this potentially transformative, one-time CAR T treatment option to more patients.”
Share:
More News
“This positive opinion from the CHMP highlights the significant unmet need and importance of effective treatment options for adult r/r B-ALL,” said Dr. Christian Itin, Chief Executive Officer of Autolus. “With FDA approval received in November 2024 and an MHRA conditional marketing authorization received in April 2025, we are on
“While we are disappointed by today’s outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies,” said Liz Barrett, President and CEO of UroGen. “The FDA carefully considers the independent advice from ODAC, and we look forward to
“Columvi in combination with GemOx demonstrated a 41% reduction in risk of death in a Phase III, randomized, multiregional clinical trial, supporting its recent approval by the European Commission and inclusion in the U.S. National Comprehensive Cancer Network treatment guidelines as a category 1 preferred regimen,” said Levi Garraway, M.D.,
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “Today’s approval marks another important milestone for InnoCare as we will celebrate our 10th anniversary this year. I would like to extend my sincere gratitude to all the physicians, patients, partners and employees who have contributed to this achievement. DLBCL
