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Amgen said the U.S. price for Imdelltra is $31,500 for the first cycle, and $30,000 for subsequent cycles. ... pivotal trial in advanced small cell lung cancer to receive full FDA approval of the ...
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]
Obecabtagene autoleucel, sold under the brand name Aucatzyl, is an anti-cancer medication used for the treatment of acute lymphoblastic leukemia. [ 1 ] [ 2 ] It is a CD19 -directed genetically modified autologous T-cell immunotherapy.
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 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.
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.
Selinexor sold under the brand name Xpovio among others, is a selective inhibitor of nuclear export used as an anti-cancer medication.It works by blocking the action of exportin 1 [6] and thus blocking the transport of several proteins involved in cancer-cell growth from the cell nucleus to the cytoplasm, which ultimately arrests the cell cycle and leads to apoptosis. [8]
Well before Risperdal was approved by the FDA and went on sale in February 1994, Johnson & Johnson had made the coming of the drug into something akin today to the launch of an Apple product. The company needed a blockbuster that would replace and surpass its original antipsychotic drug, Haldol , which had gone on sale in the late 1960s.