FDA grants priority review to therapy for relapsed leukemia, lymphoma
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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 priority review to lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) — a CD19-directed chimeric antigen receptor T-cell therapy — for treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor.
2. The agency granted orphan drug designation to LYL845 (Lyell Immunopharma) — an autologous tumor-infiltrating lymphocyte product candidate enhanced with Lyell's Epi-R manufacturing protocols — for the treatment of stage IIB to stage IV melanoma.
3. The FDA granted orphan drug designation to THIO (MAIA Biotechnology), a first-in-class cancer telomere-targeting agent, for treatment of glioblastoma.
4. The FDA granted orphan drug designation to LP-310 liposomal tacrolimus (Lipella Pharmaceuticals Inc.) for treatment of oral graft-versus-host disease.
5. The FDA approved use of PD-L1 IHC 22C3 pharmDx (Agilent Technologies Inc.) as a diagnostic tool to help identify patients with gastric or gastroesophageal junction adenocarcinoma who may be eligible for treatment with pembrolizumab (Keytruda, Merck).
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
References:
- U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (press release). Available at: https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Breyanzi-lisocabtagene-maraleucelfor-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-CLL-or-Small-Lymphocytic-Lymphoma-SLL/default.aspx. Published Nov. 9, 2023. Accessed Nov. 9, 2023.
- Lyell Immunopharma receives FDA orphan drug designation for LYL845 for the treatment of melanoma (press release). Available at: https://ir.lyell.com/news-releases/news-release-details/lyell-immunopharma-receives-fda-orphan-drug-designation-lyl845. Published Nov. 9, 2023. Accessed Nov. 10, 2023.
- FDA grants orphan drug designation to MAIA Biotechnology for THIO as a treatment for glioblastoma (press release). Available at: https://ir.maiabiotech.com/news-events/press-releases/detail/83/fda-grants-orphan-drug-designation-to-maia-biotechnology. Published Nov. 10, 2023. Accessed Nov. 10, 2023.
- FDA grants orphan designation for Lipella's LP-310 drug candidate for oral graft-versus-host disease (press release). Available at https://www.prnewswire.com/news-releases/fda-grants-orphan-designation-for-lipellas-lp-310-drug-candidate-for-oral-graft-versus-host-disease-301984199.html. Published Nov. 10, 2023. Accessed Nov. 13, 2023.
- Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx in gastric or gastroesophageal junction (GEJ) adenocarcinoma (press release). Available at: https://www.agilent.com/about/newsroom/presrel/2023/14nov-ca23039.html. Published Nov. 14, 2023. Accessed Nov. 14, 2023.
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