Keytruda Combo Approved for First-Line Treatment of HER2-Positive Gastric Cancer
The accelerated approval was based on data from the KEYNOTE-811 study.
Gastrointestinal Cancer
FDA Accepts and Grants Priority Review to New sBLA for Keytruda
Results presented at the European Society for Medical Oncology Virtual Congress 2020showed significant improvements in the primary endpoints for the pembrolizumab group.
HER2-Directed Treatment Gets Priority Review for Gastric Cancer
The supplemental Biologics License Application includes data from the open-label, randomized phase 2 DESTINY-Gatric01 trial.
New Drug Product: Qinlock
This slideshow shows drug information for Qinlock. Click here for the complete Qinlock monograph.
Qinlock Approved As Fourth-Line Treatment of Advanced GI Stromal Tumors
The FDA has approved Qinlock™ (ripretinib; Deciphera) for the treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
MPR Weekly Dose Podcast Episode 26
This week we talk about a phase 1 trial for a potential COVID-19 vaccine that is underway in Seattle; Concerns over COVID-19 and ACE inhibitor, ARB use; Safety labeling changes for SGLT2 inhibitors; A biosimilar to Herceptin; And new graphic warnings for cigarette packages.
Ayvakit Approval for GI Stromal Tumor With PDGFRA Mutation
The FDA has approved Ayvakit (avapritinib; Blueprint Medicines Corporation), a tyrosine kinase inhibitor, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
Aspirin May No Longer Have Effect in Primary CVD Prevention
Also no significant decrease seen in cancer death in studies from 2005 onward
Aspirin Use May Reduce Cancer, All-Cause Mortality in Seniors
Aspirin use three or more times per week tied to reduced all-cause, cancer, GI cancer, CRC mortality
Ogivri, a Biosimilar to Herceptin, Now Available in the US
Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab; Genentech) has been made available by Mylan and Biocon Biologics. Ogivri, a HER2/neu receptor antagonist, is indicated for: Adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with 1 high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and…
