FDA news: Lymphoma, multiple myeloma drugs receive fast track designation
The FDA announced several regulatory actions the past few weeks.
Here is an overview of decisions that may be relevant to your practice.
1. The agency granted fast track designation to AB-101 (Artiva Biotherapeutics), a nongenetically modified, cord blood-derived, allogenic, cryopreserved, antibody-dependent cell-mediated-toxicity-enhancing natural killer cell therapy. The indication is for treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin in combination with rituximab.
2. The FDA granted orphan drug designation to JBI-778 (Jubilant Therapeutics) for the treatment of glioblastoma multiforme. JBI-778 is an oral, brain-penetrant and substrate-competitive protein arginine methyl transferase 5 (PRMT5) inhibitor.
3. The FDA granted regenerative medicine advanced therapy and fast track designation to equecabtagene autoleucel (CT103A, IASO Biotherapeutics) for relapsed or refractory multiple myeloma. CT103A is a B-cell maturation antigen (BCMA)-directed autologous chimeric antigen receptor T-cell injection.
4. The agency granted priority review to elranatamab (Pfizer), an investigational humanized BCMA CD3-targeted bispecific antibody, for treatment of relapsed or refractory multiple myeloma. The agency based the decision on results of the phase 2 MagnetisMM-3 trial.
5. The FDA granted breakthrough therapy designation to mRNA-4157/V940 (Moderna), in combination with pembrolizumab (Keytruda, Merck), for high-risk melanoma following complete resection. The agency based the designation on positive data from the phase 2b KEYNOTE-942 trial.
6. The agency granted a new drug application and priority review to nirogacestat (SpringWorks Therapeutics) for treatment of adults with desmoid tumors. Nirogacestat is an investigational gamma secretase inhibitor.
References:
- Artiva Biotherapeutics receives FDA fast track designation for AB-101 (press release). Available at: www.artivabio.com/artiva-biotherapeutics-receives-fda-fast-track-designation-for-ab-101/. Published Jan. 31, 2023. Accessed Feb. 27, 2023.
- Jubilant Therapeutics Inc. receives orphan drug designation for the PRMT5 inhibitor – JBI-778 for the treatment of glioblastoma multiforme (GBM) (press release). Available at: www.jubilanttx.com/pressreleasedetails.aspx?mpgid=1473&pgid=1475&pressid=492. Published Feb. 13, 2023. Accessed Feb. 27, 2023.
- IASO Bio Announces CT103A granted regenerative medicine advanced therapy (RMAT) and fast track (FT) designations by the FDA (press release). Available at: www.iasobio.com/info.php?id=215. Published Feb. 13, 2023. Accessed Feb. 27, 2023.
- Pfizer’s elranatamab receives FDA and EMA filing acceptance (press release). Available at: www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-receives-fda-and-ema-filing-acceptance. Published Feb. 22, 2023. Accessed Feb. 27, 2023.
- Moderna and Merck announce mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with Keytruda (pembrolizumab), was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection (press release). Available at: www.merck.com/news/moderna-and-merck-announce-mrna-4157-v940-an-investigational-personalized-mrna-cancer-vaccine-in-combination-with-keytruda-pembrolizumab-was-granted-breakthrough-therapy-designation-by-the/. Published Feb. 22, 2023. Accessed Feb. 27, 2023.
- SpringWorks Therapeutics announces FDA acceptance and priority review of new drug application for nirogacestat for the treatment of adults with desmoid tumors (press release). Available at: ir.springworkstx.com/news-releases/news-release-details/springworks-therapeutics-announces-fda-acceptance-and-priority. Published Feb. 27, 2023. Accessed Feb. 27, 2023.