FDA grants priority review to myelodysplastic syndrome, prostate cancer therapies
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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 FDA granted priority review to a supplemental new drug application seeking approval of ivosidenib tablets (Tibsovo, Servier) for treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory myelodysplastic syndrome. Ivosidenib tablets are approved in the U.S. for treatment of certain patients with IDH1-mutated acute myeloid leukemia.
2. The agency granted priority review to enzalutamide (Xtandi; Pfizer, Astellas) for the treatment of men with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. Enzalutamide — an androgen receptor signaling inhibitor — is approved in several countries for men with metastatic castration-sensitive prostate cancer, metastatic castration-resistant prostate cancer and nonmetastatic castration-resistant prostate cancer.
3. The FDA granted orphan drug designation to NXC-201 (Nexcella) — a chimeric antigen receptor T-cell therapy that targets B-cell maturation agent — for treatment of multiple myeloma.
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:
- Servier announces FDA filing acceptance and priority review for Tibsovo (ivosidenib tablets) in the treatment of IDH1-mutated relapsed or refractory (R/R) myelodysplastic syndromes (press release). Available at: https://servier.us/blog/servier-announces-fda-filing-acceptance-and-priority-review-for-tibsovo-ivosidenib-tablets-in-the-treatment-of-idh1-mutated-relapsed-or-refractory-r-r-myelodysplastic-syndromes-mds/. Published Aug. 15, 2023. Accessed Aug. 15, 2023.
- FDA grants priority review for Xtandi in non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence (press release). Available at: https://newsroom.astellas.us/2023-08-23-FDA-Grants-Priority-Review-for-XTANDI-R-in-Non-Metastatic-Castration-Sensitive-Prostate-Cancer-with-High-Risk-Biochemical-Recurrence. Published Aug. 23, 2023. Accessed Aug. 23, 2023.
- U.S. Food and Drug Administration approves orphan drug designation for NXC-201 as a treatment for multiple myeloma (press release). Available at: https://nexcella.com/2023/08/23/u-s-food-and-drug-administration-approves-orphan-drug-designation-for-nxc-201-as-a-treatment-for-multiple-myeloma/. Published Aug. 23, 2023. Accessed Aug. 23, 2023.
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