Oncology

The FDA’s decision was based on data from the phase 3 CARTITUDE-4 clinical trial (NCT04181827).

Review top news and interview highlights from the week ending April 5, 2024.

The approval comes a couple weeks after ODAC voted in favor of Abecma’s benefit-risk profile and sBLA.

Investigators observed no notable toxicities including cytokine release syndrome, neurotoxicity or graft-versus-host disease.

Uttam Rao, MD, MBA, a transplant physician at St. David's South Austin Medical Center of Sarah Cannon, discussed research comparing patient outcomes on different conditioning regimens for CAR-T.

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The assistant professor at Mayo Clinic School of Medicine discussed plans for further research and a phase 2/3 study.

Judy Lieberman, MD, PhD, the endowed chair in cellular and molecular medicine at Boston Children’s Hospital, discussed how there is still much room for growth for RNA therapeutics despite progress so far.

Zever-cel is being assessed in the phase 2 LUMMICAR-2 trial (NCT03915184) in North America, previously reporting results of an ORR of 100% among 11 patients.

Review top news and interview highlights from the week ending March 29, 2024.

The clinical investigator in the Department of Bone Marrow Transplantation & Cellular Therapy at St. Jude Children’s Research Hospital discussed several areas of interest for research now that CAR-T is here to stay.

Judy Lieberman, MD, PhD, the endowed chair in cellular and molecular medicine at Boston Children’s Hospital, discussed her research on siRNA technology.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

Notably, the combination therapy, referred to as SYNCAR-001 + STK-009, will be administered in the trial without the use of lymphodepletion.

The company noted that it plans to submit the BLA in the second quarter of 2024.

In March 2024, the FDA approved the CAR T-cell therapy lisocabtagene maraleucel (Breyanzi) as a treatment for relapsed or resistant chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

John Ligon, MD, an assistant professor in the department of pediatrics at the University of Florida College of Medicine, discussed his view of the main priorities for research in this area.

The associate professor of medicine, Medical College of Wisconsin, discussed advantages of afami-cel and data from the pivotal SPEARHEAD-1 trial.

The endowed chair in cellular and molecular medicine at Boston Children’s Hospital discussed the rapid advancements in RNA-based treatments in the past 2 decades and potential advancements that remain on the horizon.

The professor from Cedars Sinai discussed how the cell therapy stands to revolutionize the treatment landscape.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

John Ligon, MD, an assistant professor in the department of pediatrics at the University of Florida College of Medicine, discussed his team’s early findings on CAR-T and fertility from CIBMTR centers.

At the 2-month follow-up PET/CT scan, the patient showed a 6.6% reduction in tumor size.

In February 2024, the FDA approved a tumor-infiltrating lymphocyte therapy called lifileucel for people with advanced melanoma.