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In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Avacopan was approved for medical use in Japan in September 2021, [7] and in the United States in October 2021. [5] [8] [9] It is the first orally-administered inhibitor of the complement C5a receptor approved by the US Food and Drug Administration (FDA). [8] The FDA considers it to be a first-in-class medication. [10]
Dostarlimab was approved for the treatment of endometrial cancer in both the United States and the European Union in April 2021. [5] [6] [11] [8] [12] Based on the Garnet trial, dostarlimab gained accelerated approval from the US Food and Drug Administration (FDA) in April 2021, [6] and full approval in February 2023. [7]
Maralixibat chloride, sold under the brand name Livmarli, is a medication used to treat cholestatic pruritus in people with Alagille syndrome. [5] [6] Maralixibat chloride is an ileal bile acid transporter (IBAT) inhibitor.
Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. [1] It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein. [1]
Trilaciclib is the first therapy in its class and was approved for medical use in the United States in February 2021. [2] [5] The U.S. Food and Drug Administration considers it to be a first-in-class medication. [6] Chemotherapy drugs are designed to kill cancer cells but can damage normal tissues as well. [2]
Selumetinib was approved for medical use in the United States in April 2020, [15] and in the European Union in June 2021. [9] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication .
In March 2021, the FDA granted regular approval to lorlatinib based on data from study B7461006 (NCT03052608), a randomized, multicenter, open-label, active-controlled trial conducted in 296 participants with ALK-positive metastatic non-small cell lung cancer who had not received prior systemic therapy for metastatic disease.