FDA Oncology Drug Approvals Granted Between May 21, 2018 and May 14, 2019

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Jun 3, 2019 - Many important drugs for the treatment of cancer were approved by the FDA from the period of May 21 2018 to May 14 2019. Of note is Tecentriq which was approved in March 2018 and Talzenna in October 2018, both for locally advanced or metastatic TNBC. However, in the case of Tecentriq, only tumors with the PD-L1 marker were likely to respond and for Talzenna, only women with a BRCA mutation are eligible for treatment. These criteria means that most women diagnosed with TNBC are still not able to access these treatments because PD-L1 expression and BRCA mutations are only found in small subsets of women with TNBC. As there are no targeted therapies available for most TNBC, it remains a major unmet medical need.

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