Approvals and designations made by the U.S. Food and Drug Administration for the week ended Dec. 20.
Approvals
* AstraZeneca PLC and Daiichi Sankyo Co. Ltd.'s Enhertu, for HER2-positive breast cancer that has spread across the body or has metastasized after receiving two or more therapies.
* Merck & Co. Inc.'s Ervebo, for preventing Ebola virus disease.
* Pfizer Inc. and Astellas Pharma Inc.'s Xtandi for metastatic castration-sensitive prostate cancer.
* Seattle Genetics Inc. and Astellas Pharma's Padcev for adult patients with locally advanced or spreading urothelial cancer who have not responded to a PD-1/L1 inhibitor and platinum-containing chemotherapy.
* Avadel Pharmaceuticals PLC's Nouress injection for neonatal patients that require total parenteral nutrition.
* Medtronic PLC's Stealth Autoguide robotic system for positioning assistance during neurosurgical procedures.
* Elekta AB (publ)'s Elekta Unity technology in diffusion-weighted imaging.
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FDA headquarters in Silver Spring, Md.Priority review
* UroGen Pharma Ltd.'s UGN-101, for low-grade upper tract urothelial cancer.
* Pfizer's Braftovi, in combination with Eli Lilly and Co.'s Erbitux for its expanded use in treating patients with BRAF-mutant colorectal cancer who have received either one or two prior therapies.
Fast track
* Kura Oncology Inc.'s tipifarnib for patients with HRAS mutant head and neck squamous cell carcinomas after progression on platinum therapy.
* Salarius Pharmaceuticals Inc.'s seclidemstat for Ewing sarcoma.
Breakthrough therapy
* Agios Pharmaceuticals Inc.'s Tibsovo for relapsed or refractory myelodysplastic syndrome that have a mutation called isocitrate dehydrogenase 1, or IDH1.
* Seattle Genetics' tucatinib, in combination with Roche Holding AG's Herceptin and Xeloda for HER2-positive breast cancer patients whose disease has spread to nearby tissue or lymph nodes and cannot be surgically removed or has spread to other parts of the body.
Other designations
* Orphan drug, for Eagle Pharmaceuticals Inc.'s Ryanodex for organophosphate exposure.
* Orphan drug, for Prevail Therapeutics Inc.'s gene therapy PR006 for frontotemporal dementia patients with a GRN gene mutation.
* Orphan drug, for Cytokinetics Inc.'s reldesemtiv for amyotrophic lateral sclerosis.