Wyanoke GroupFDA Grants Fast Track Status to Cosela for Triple-Negative Breast Cancer (TNBC)

Trilaciclib (Cosela, G1 Therapeutics), a cyclin dependent kinase 4/6 inhibitor, is already approved in the United States to reduce frequency of chemotherapy-related bone marrow suppression among adults with extensive-stage small cell lung cancer. Now, the FDA has granted fast track designation to the drug for use in combo with chemo for treatment of locally advanced […]

HMP CommunicationsFDA Approves Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC

Another win for Merck and Keytruda, as the FDA granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 based on PFS. The FDA also approved a companion diagnostic, PD-L1 IHC 22C3 pharmDx.