Blueprint Medicines Corporation’s AYVAKIT (avapritinib) was approved for adult patients with a specific type of unresectable or metastatic gastrointestinal stromal tumor (GIST). Recently, the FDA announced that a natural history study aiming to better understand the course and treatment of patients with GIST provided supportive evidence for AYVAKIT (avapritinib). Read more here.
In somewhat of a reversal, Pfizer also was able to provide supportive evidence for a label expansion for IBRANCE (Palbociclib). IBRANCE (palbociclib) is now FDA approved for treatment of male breast cancer. However, males with breast cancer were initially excluded from clinical studies of Palbociclib. Endocrine therapy alpng with RWE from EHR data was later submitted to support the use of palbociclib . Read more here.