Author | Nichole Tucker


FDA Grants Priority Review to Frontline Cemiplimab for PD-L1-High Advanced or Metastatic NSCLC

October 29, 2020

The FDA has accepted the supplemental Biologics License Application for cemiplimab-rwlc and granted it Priority Review for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer with ≥50% PD-L1 expression.

MYC Status Relevant to Risk Stratification in Newly Diagnosed Multiple Myeloma

October 29, 2020

In evaluating MYC rearrangement and its correlation with disease burden and prognostics in newly diagnosed multiple myeloma, a group of Mayo Clinic investigators found that the alteration is associated with high disease burden and independently prognosticates adverse outcomes in patients.

FoundationOne Liquid CDx Granted New and Expanded FDA Indications in Various Solid Tumors

October 28, 2020

The FDA has granted approval to the FoundationOne Liquid CDx as a companion diagnostic indicated for the to identify patients who may derive benefit from treatment with 3 FDA-approved targeted therapies, including alpelisib, rucaparib, and alectinib.