The mm Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mm Hub cannot guarantee the accuracy of translated content. The mm and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Multiple Myeloma Hub is an independent medical education platform, sponsored by Bristol Myers Squibb, GSK, Johnson & Johnson, Pfizer, Roche and Sanofi. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View mm content recommended for you
FDA grants regenerative medicine advanced therapy designation to ALLO-715 for RRMM
On April 21, 2021, it was announced that the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to ALLO-715 for the treatment of relapsed/refractory multiple myeloma (RRMM).1 Designation was based on promising data from the ongoing phase I UNIVERSAL trial (NCT04093596), which has been summarized on the Multiple Myeloma Hub. Initial results demonstrated deep clinical responses and a promising safety profile when using a combination of ALLO-715 with the CD52-targeting monoclonal antibody, ALLO-647, for heavily pretreated patients with RRMM.1
The advantages of the RMAT designation include all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with the FDA, which may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval. You can find the requirements for RMAT designation here.2
ALLO-715 is an allogeneic chimeric antigen receptor (CAR) T-cell product that targets the B-cell maturation antigen (BCMA). Importantly, these cells lack CD52, allowing for lymphodepletion with ALLO-647 with no effect on the CAR-T product. Additionally, they overcome some of the manufacturing challenges of using autologous CAR T cells, reducing the timelines significantly and eliminating the need for bridging therapy.1
The UNIVERSAL trial continues to enroll patients to optimize the dosage for ALLO-715 and ALLO-647 and explore the combination of ALLO-715 with the investigational gamma secretase inhibitor, nirogacestat, which increases BCMA cell-surface levels.1
An updated announcement on August 12, 2021, declared that the product has been granted orphan drug designation by the FDA for the treatment of patients with RRMM.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content