FDA news: License applications accepted for melanoma, endometrial cancer therapies
Click Here to Manage Email Alerts
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 fast track designation to IMPT-314 (ImmPACT Bio) — a CD19/CD20 chimeric antigen receptor T-cell therapy — for the treatment of patients with B-cell mediated malignancies.
2. The FDA granted orphan drug designation to ATG-022 (Antengene) — a claudin 18.2-targeting antibody-drug conjugate — for the treatment of gastric cancer and pancreatic cancer.
3. The agency granted priority review to fruquintinib (Takeda) for the treatment of patients with previously treated colorectal cancer. Fruquintinib is a potent, highly selective inhibitor of VEGFR-1, -2 and -3.
4. The FDA granted priority review to repotrectinib (Bristol Myers Squibb) for treatment of certain patients with non-small cell lung cancer. The indication applies to patients with ROS1-positive locally advanced or metastatic disease. The decision was based on results of the TRIDENT-1 trial.
5. The agency accepted a biologics license application for lifileucel (Iovance Biotherapeutics) for the treatment of patients with advanced melanoma. Lifileucel is a tumor infiltrating lymphocyte therapy intended for patients with advanced melanoma that progressed on or after prior anti-PD-1/L1 therapy and targeted therapy.
6. The FDA approved flotufolastat F 18 (Posluma, Blue Earth Diagnostics) for PET of prostate-specific membrane antigen (PSMA)-positive lesions in certain men with prostate cancer. Posluma is an optimized PSMA-targeted molecule that binds to and is internalized by cells that express PSMA.
7. The FDA accepted a supplemental biologics license application to dostarlimab (Jemperli, GSK) in combination with chemotherapy for treatment of certain patients with endometrial cancer. The indication applies to patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent disease.
8. The FDA granted orphan drug status to BRG01 (Biosyngen), an immune cell therapy, for the treatment of nasopharyngeal cancer.
9. A supplemental biologics license application has been submitted to FDA for approval of ciltacabtagene autoleucel (Carvykti; Janssen) for treatment of adult patients with relapsed or refractory multiple myeloma. The indication applies to patients who received at least one prior line of therapy.
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.
FDA grants fast track designation to facilitate development and expedite review of drugs that fill an unmet medical need in a serious condition, thus enabling the agents to reach patients sooner.
References:
- ImmPACT Bio granted FDA fast track designation for IMPT-314 in patients with relapsed or refractory aggressive B-cell lymphoma (press release). Available at: https://immpact-bio.com/news-and-events/immpact-bios-impt-314-receives-fast-track-status-from-us-fda/. Published May 15, 2023. Accessed June 12, 2023.
- Antengene announces claudin 18.2 antibody-drug conjugate ATG-022 granted orphan drug designations by the U.S. FDA for the treatment of gastric and pancreatic cancers (press release). Available at: https://www.antengene.com/newsinfo/323. Published May 23, 2023. Accessed June 12, 2023.
- Takeda and HUTCHMED announce new drug application (NDA) for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review (press release). Available at: https://www.takeda.com/newsroom/press-releases/2023/takeda-and-hutchmed-announce-new-drug-application-for-fruquintinib-for-treatment-of-previously-treated-metastatic-colorectal-cancer-granted-priority-review/. Published May 25, 2023. Accessed June 12, 2023.
- U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for repotrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (press release). Available at: https://news.bms.com/news/details/2023/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Repotrectinib-for-the-Treatment-of-Patients-with-Locally-Advanced-or-Metastatic-ROS1-Positive-Non-Small-Cell-Lung-Cancer/default.aspx. Published May 30, 2023. Accessed June 12, 2023.
- Iovance Biotherapeutics announces U.S. Food and Drug Administration acceptance of the biologics license application of lifileucel for the treatment of advanced melanoma (press release). Available at: https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-us-food-and-drug. Published May 26, 2023. Accessed June 12, 2023.
- U.S. FDA approves Blue Earth Diagnostics’ POSLUMA (flotufolastat F 18) injection, first radiohybrid PSMA-targeted PET imaging agent for prostate cancer (press release). Available at: https://www.blueearthdiagnostics.com/news. Published May 30, 2023. Accessed June 12, 2023.
- GSK receives U.S. FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H primary advanced or recurrent endometrial cancer (press release). Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-file-acceptance-for-jemperli/. Published June 6, 2023. Accessed June 12, 2023.
- Biosyngen’s cell therapy BRG01 granted orphan drug designation by the U.S. FDA for treatment of nasopharyngeal cancer (press release). Available at: https://www.biosyngen.com/index.php?m=home&c=View&a=index&aid=101. Published June 5, 2023. Accessed June 12, 2023.
- Janssen submits supplemental biologics license application to U.S. FDA seeking approval of CARVYKTI for the earlier treatment of patients with relapsed or refractory multiple myeloma (press release). Available at: https://www.janssen.com/janssen-submits-supplemental-biologics-license-application-us-fda-seeking-approval-carvyktir-earlier. Published June 6, 2023. Accessed June 12, 2023.
Collapse
Press Releases
Read more about
Click Here to Manage Email Alerts