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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 on Thursday granted accelerated approval to Amgen's tarlatamab, a targeted immunotherapy for adults in the advanced stages of hard-to-treat small cell lung ...
The U.S. Food and Drug Administration (FDA) approved trastuzumab emtansine in February 2013, and granted the application for Kadcyla to Genentech. [18] The FDA granted the application for trastuzumab emtansine priority review and breakthrough therapy designations. [24] In 2013, trastuzumab emtansine was approved in the UK, [4] and the EU. [6]
In 2016, the FDA approved atezolizumab for urothelial carcinoma and non-small cell lung cancer. Avelumab (Bavencio) is a fully human IgG1 antibody developed by Merck Serono and Pfizer. Avelumab is FDA approved for the treatment of metastatic merkel-cell carcinoma. It failed phase III clinical trials for gastric cancer. [33]
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]
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 ]
Tarlatamab, sold under the brand name Imdelltra, is an anti-cancer medication used for the treatment of extensive-stage small cell lung cancer. [2] It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3.
It was approved in 2014. Nivolumab is approved to treat melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancer, and Hodgkin's lymphoma. [16] Pembrolizumab (brand name Keytruda) is another PD-1 inhibitor that was approved by the FDA in 2014 and was the second checkpoint inhibitor approved in the United States. [17]
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