FDA grants fast track designation to leukemia, lymphoma and endometrial cancer therapies
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The FDA announced several regulatory actions.
Here is an overview of decisions that may be relevant to your practice.
1. The FDA granted fast track designation to vididencel (Mendus AB) for treatment of patients with acute myeloid leukemia in complete remission with residual disease. Vididencel is an off-the-shelf, intradermal vaccine derived from Mendus AB's proprietary DCOne leukemic cell line.
2. The agency granted fast track designation to AFM13 (Affimed N.V.) in combination with AB-101 (AlloNK, Affimed N.V) for treatment of relapsed or refractory Hodgkin lymphoma. AFM13 is an innate cell engager. AB-101 is a non-genetically modified, cord blood-derived, allogeneic natural killer cell therapy.
3. The FDA granted fast track designation to tulmimetostat (MorphoSys) — a dual inhibitor of EZH1 and EZH2 — for treatment of women with advanced recurrent or metastatic endometrial cancer that harbors AT-rich interacting domain containing protein 1A (ARID1A) mutations and who progressed on at least one prior line of treatment.
4. The FDA granted orphan drug designation to a novel drug conjugate developed by CyGenica Limited for treatment of glioblastoma multiforme.
Orphan drug designation is given to treatments that address rare diseases affecting fewer than 200,000 people in the United States. The designation provides assistance in developing drugs, tax credits, exemptions from FDA fees and 7 years of marketing exclusivity.
References:
- Mendus receives U.S. FDA fast track designation for vididencel in acute myeloid leukemia (press release). Available at: https://mendus.com/news/mendus-receives-u-s-fda-fast-track-designation-for-vididencel-in-acute-myeloid-leukemia-aml. Published Sept. 8, 2023. Accessed Sept. 8, 2023.
- Affimed receives FDA fast track designation for AFM13 in combination with AlloNK for the treatment of patients with relapsed or refractory Hodgkin lymphoma (press release). Available at: https://www.affimed.com/affimed-receives-fda-fast-track-designation-for-afm13-in-combination-with-allonk-for-the-treatment-of-patients-with-relapsed-or-refractory-hodgkin-lymphoma/. Published Sept. 12, 2023. Accessed Sept. 12, 2023.
- MorphoSys receives U.S. FDA fast track designation for tulmimetostat in endometrial cancer (press release). Available at: https://www.morphosys.com/en/news/morphosys-receives-us-fda-fast-track-designation-tulmimetostat-endometrial-cancer. Published Sept. 12, 2023. Accessed Sept. 13, 2023.
- CyGenica Limited secures US FDA approval for orphan drug designation for novel drug conjugate in glioblastoma multiforme treatment (press release). Available at: https://www.biospace.com/article/releases/cygenica-limited-secures-usfda-approval-for-orphan-drug-designation-for-novel-drug-conjugate-in-glioblastoma-multiforme-treatment. Published Sept. 12, 2023. Accessed Sept. 12, 2023.
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