The FDA accepted a supplemental biologics license application and granted a priority review to durvalumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer.
The FDA has granted a priority review to a new drug application for pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
A perioperative study confirmed brain penetrance and robust biomarker suppression in patients with low-grade glioma with an IDH1 mutation.
Henlius announced that their multicenter phase III study met its primary end point of best overall response rate at week 24.
Takeda announced that their ongoing phase III ALTA-1L trial of brigatinib reduced the risk of disease progression or death in adults with advanced ALK-positive non-small cell lung cancer.
Predictive models demonstrated the ability to anticipate adverse opioid-related outcomes among cancer survivors.
As part of Project Orbis, The FDA has approved acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
MorphoSys announced that their ongoing phase III B-MIND study of tafasitamab passed the interim analysis for futility in patients with relapsed or refractory diffuse large B-cell lymphoma.
Samsung Bioepis announced that the FDA accepted a biologics license application for SB8, a biosimilar candidate for bevacizumab.
Myovant announced that their phase III HERO study of relugolix met its primary efficacy end point and all 6 secondary endpoints in men with advanced prostate cancer.