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The US Food and Drug Administration (FDA) approved Lifileucel through the accelerated approval pathway and granted the application orphan drug, regenerative medicine advanced therapy, fast track, and priority review designations under the brand name Amtagvi to Iovance Biotherapeutics. [3]
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
The FDA has a "priority review process" for drugs which compete with another drug whose price exceeds its value-based price. Congress could also grant the FDA the ability to change the exclusivity period for new drugs. [6] The FDA could also temporarily allow the import of drugs approved for sale outside the United States. [65]
The U.S. Food and Drug Administration (FDA) granted zanubrutinib priority review, accelerated approval, breakthrough therapy, and orphan drug designations. [ 10 ] [ 15 ] [ 23 ] The FDA approved zanubrutinib in November 2019, and granted the application for Brukinsa to BeiGene USA Inc. [ 10 ] [ 15 ] [ 24 ]
Tucatinib is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of adults with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
The concept of blocking PD-1 and PD-L1 for the treatment of cancer was first published in 2001. [6] Pharmaceutical companies began attempting to develop drugs to block these molecules, and the first clinical trial was launched in 2006, evaluating nivolumab.
Bexarotene, sold under the brand Targretin, is an antineoplastic (anti-cancer) agent used for the treatment of cutaneous T cell lymphoma (CTCL). [4] It is a third-generation retinoid. [5] It was approved by the U.S. Food and Drug Administration (FDA) in December 1999, and the European Medicines Agency (EMA) in March 2001.
Capmatinib was approved for medical use in the United States in May 2020. [7] [8] Capmatinib is the first therapy approved by the US Food and Drug Administration (FDA) to treat non-small cell lung cancer with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping). [4]