FDA news: Prostate cancer, renal cell carcinoma therapies receive fast track designation
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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 fast track designation to ARX517 (Ambrx) — an anti-prostate-specific membrane antigen antibody-drug conjugate — for the treatment of metastatic castration-resistant prostate cancer. The phase 1/phase 2 APEX-01 trial is evaluating the therapy for certain men with metastatic disease whose tumors progressed on at least two prior FDA-approved treatments.
2. The FDA issued a complete response letter to Citius Pharmaceuticals regarding the company’s biologics license application seeking approval of denileukin diftitox (Lymphir) for treatment of patients with relapsed or refractory cutaneous T-cell lymphoma who received at least one prior systemic therapy. The agency required Citius to incorporate enhanced product testing of denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein.
3. The FDA granted fast track designation to IVS-3001 (Invectys Inc.) for treatment of patients with HLA-G-positive locally advanced or metastatic clear cell renal cell carcinoma who failed or were intolerant to standard therapies. IVS-3001 is a chimeric antigen receptor T-cell therapy that targets HLA-G, an immune checkpoint and tumor-specific antigen.
4. The agency granted orphan drug designation to elraglusib (Actuate) — a small molecule glycogen synthase kinase-3 beta inhibitor — for treatment of pancreatic cancer.
5. The FDA granted orphan drug designation to SNB-101 (SN Bioscience Inc.) for treatment of small cell lung cancer. The agent is a nanoparticle anticancer drug developed using the active metabolite of irinotecan, SN-38, as an active pharmaceutical ingredient.
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:
- FDA grants fast track designation for Ambrx’s ARX517 for the treatment of metastatic castration-resistant prostate cancer (press release). Available at: https://ir.ambrx.com/news/news-details/2023/FDA-Grants-Fast-Track-Designation-for-Ambrxs-ARX517-for-the-Treatment-of-Metastatic-Castration-Resistant-Prostate-Cancer/default.aspx. Published July 19, 2023. Accessed July 20, 2023.
- Citius Pharmaceuticals Inc. receives a complete response letter from the U.S. Food and Drug Administration (FDA) for Lymphir (denileukin diftitox) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (press release). Available at: https://citiuspharma.com/investors/news-media/news/release-details/2023/Citius-Pharmaceuticals-Inc.-Receives-a-Complete-Response-Letter-from-the-U.S.-Food-and-Drug-Administration-FDA-for-LYMPHIR-Denileukin-Diftitox-for-the-Treatment-of-Patients-with-Relapsed-or-Refractory-Cutaneous-T-Cell-Lymphoma/default.aspx. Published July 29, 2023. Accessed July 31, 2023.
- FDA grants fast track designation to IVS-3001, a CAR T-cell therapy, in the treatment of renal cell carcinoma (press release). Available at: https://finance.yahoo.com/news/fda-grants-fast-track-designation-100000295.html. Published July 31, 2023. Accessed Aug. 1, 2023.
- Actuate Therapeutics receives FDA orphan drug designation for elraglusib for treatment of pancreatic cancer (press release). Available at: https://actuatetherapeutics.com/press-releases/actuate-therapeutics-receives-fda-orphan-drug-designation-for-elraglusib-for-treatment-of-pancreatic-cancer/. Published Aug. 1, 2023. Accessed Aug. 1, 2023.
- US FDA grants orphan drug designation of SN Bioscience’s nano anti-cancer drug ‘SNB-101’ for small cell lung cancer (press release). Available at: https://www.prnewswire.com/news-releases/us-fda-grants-orphan-drug-designation-of-sn-biosciences-nano-anti-cancer-drug-snb-101-for-small-cell-lung-cancer-301882684.html. Published July 20, 2023. Accessed Aug. 2, 2023.
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