FDA Committee Votes in Favor of B-Cell Acute Lymphoblastic Leukemia Drug


CTL019 is a chimeric antigen receptor T cell therapy.

Yesterday, the FDA Oncologic Drugs Advisory Committee voted unanimously in favor of the Biologics License Application for CTL019 (tisagenlecleucel) to treat pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

CTL019 is an investigational chimeric antigen receptor T cell therapy that represents a new therapeutic approach to fill the lack of treatment options for patients with this disease, according to a press release.

Last month, updated results from the phase 2 ELIANA trial showed that 83% of pediatric patients achieved complete remission (CR) or CR with incomplete blood count recovery within the first 3 months of treatment. No minimal residual disease was discovered among these patients.

Findings from the ELIANA study also showed that patients had a relapse probability of 75% at 6 months, which dropped to 64% at 12 months. Furthermore, the probability of survival was 89% at 6 months and 79% at 12 months.

“Novartis has long believed in the potential of chimeric antigen receptor T cell therapies to change the cancer treatment paradigm,” the manufacturer said in a release. “And we thank the FDA ODAC for its recommendation, and extend our deepest gratitude to the patients and families who have participated in our clinical trials to advance this important research.”

ALL is a fast-growing cancer of lymphoblasts, according to the American Cancer Society. In approximately 80% to 85% of children with this disease, the leukemia start in B cells.

Patient advocacy groups praised the FDA’s findings and the impact the new treatment could have on patients with ALL.

“The Leukemia & Lymphoma Society (LLS) applauds today’s unanimous decision of the FDA advisory panel on Novartis’ CAR-T immunotherapy, which marks a significant breakthrough for cancer patients,” the LLS stated in a press release. “The Leukemia & Lymphoma Society was an early supporter of CAR-T therapy, including a $21 million investment in the work of Carl June and his team at University of Pennsylvania and Children’s Hospital of Philadelphia, over the past 2 decades. We are hopeful about the promise of immunotherapy approaches for cancer patients, who deserve new and more effective treatments.”

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