FDA news: Urothelial cancer therapies get priority review, fast track designations
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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 agency granted priority review to enfortumab vedotin-ejfv (Padcev; Astellas Oncology, Seagen) and pembrolizumab (Keytruda, Merck) as combination treatment for patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.
2. The FDA granted fast track designation to BT8009 (Bicycle Therapeutics) for adults with previously treated locally advanced or metastatic urothelial cancer. BT8009 is a potential first-in-class Bicycle toxin conjugate that targets nectin-4, a protein highly expressed in urothelial cancer.
2. The FDA granted orphan drug designation to ZB131 (ZielBio) for treatment of pancreatic cancer. ZB131 is a proprietary monoclonal antibody. The FDA approved ZB131 for treatment of cholangiocarcinoma in November.
4. The FDA granted priority review to glofitamab (Genentech) for treatment of adults with relapsed or refractory large B-cell lymphoma. Glofitamab is an investigational CD20 and CD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. The indication applies to adults that received two or more lines of systemic therapy.
5. The FDA granted orphan drug designation to JBI-802 (Jubilant Therapeutics) for treatment of small cell lung cancer and acute myeloid leukemia. JBI-802 is an oral, potent and selective dual inhibitor of two epigenetic targets of that CoREST complex, targeting stem cell modulation while also modulating immune suppression.
6. The FDA granted orphan drug designation to azeliragon (Cantex Pharmaceuticals) for treatment of glioblastoma. Azeliragon is an orally active, small molecule antagonist of the receptor for advanced glycation endproducts interactions with certain ligands.
References:
- Bicycle Therapeutics. Bicycle Therapeutics announces FDA fast track designation granted to BT8009 for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer (press release). Available at: https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-fda-fast-track-designation. Published Jan. 4, 2023. Accessed Jan. 9, 2023.
- Cantex Pharmaceuticals. Cantex Pharmaceuticals receives FDA orphan drug designation for azeliragon for the treatment of glioblastoma (press release). Available at: https://www.prnewswire.com/news-releases/cantex-pharmaceuticals-receives-fda-orphan-drug-designation-for-azeliragon-for-the-treatment-of-glioblastoma-301716178.html. Published Jan. 9, 2023. Accessed Jan. 9, 2023.
- Genentech. FDA grants priority review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-Cell lymphoma (press release). Available at: https://www.gene.com/media/press-releases/14980/2023-01-05/fda-grants-priority-review-to-genentechs. Published on Jan. 5, 2023. Accessed on Jan. 9, 2023.
- Jubilant Therapeutics. Jubilant Therapeutics Inc. receives orphan drug designation for JBI-802 for acute myeloid leukemia (AML) and small cell lung cancer (SCLC) (press release). Available at: https://www.jubilanttx.com/pressreleasedetails.aspx?mpgid=1473&pgid=1475&pressid=489. Published on Jan. 5, 2023. Accessed on Jan. 9, 2023.
- Seagen. Seagen, Astellas and Merck Announce FDA acceptance of sBLAs for Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for the first-line treatment of certain patients with locally advanced or metastatic urothelial cancer (press release). Available at: https://investor.seagen.com/press-releases/news-details/2022/Seagen-Astellas-and-Merck-Announce-FDA-Acceptance-of-sBLAs-for-PADCEV-enfortumab-vedotin-ejfv-with-KEYTRUDA-pembrolizumab-for-the-First-Line-Treatment-of-Certain-Patients-With-Locally-Advanced-or-Metastatic-Urothelial-Cancer/default.aspx. Published Dec. 20, 2022. Accessed Jan. 9, 2023.
- ZielBio. ZielBio receives orphan drug designation for ZB131 for the treatment of pancreatic cancer (press release). Available at: https://www.prnewswire.com/news-releases/zielbio-receives-orphan-drug-designation-for-zb131-for-the-treatment-of-pancreatic-cancer-301709748.html. Published Dec. 27, 2022. Accessed Jan. 9, 2023.
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