FDA to Review Additional GI Cancer Indications for Nivolumab
The sBLA submissions were based on data from the CheckMate -649 and CheckMate -577 trials.
Colorectal And Other GI Cancers
Enhertu Gains Gastric Cancer Indication
The approval was based on data from the phase 2 DESTINY-Gastric01 trial.
Sutab Tablets Now Available for Colonoscopy Prep
The product is administered as a split-dose regimen consisting of 2 doses.
Pembrolizumab Slows MSI-H-dMMR Metastatic CRC
Pembrolizumab superior to chemo for progression-free survival among patients who had not previously received treatment
MPR Weekly Dose Podcast Episode 56
This week we cover a study that identified factors associated with strong antibody responses to COVID; How convalescent plasmas benefits may be limited; A nasal spray to treat diabetic gastroparesis; Recommendations for colorectal cancer screening; And a new treatment approved for dry eye disease. And of course, movie trivia!
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.
USPSTF Issues Draft Recommendation for CRC Screening
Benefit substantial for adults aged 50 to 75 years; benefit moderate for adults aged 45 to 49 years.
FDA Denies Accelerated Approval of Keytruda Plus Lenvima for Unresectable HCC
In the CRL, the FDA stated that the data from KEYNOTE-524/Study 116 did not demonstrate a meaningful advantage over available therapies for unresectable or metastatic HCC.
Keytruda Approved as First-Line Treatment of MSI-H or dMMR Colorectal Cancer
The FDA has approved Keytruda (pembrolizumab; Merck), a programmed death receptor-1 -blocking antibody, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
FDA Approves Keytruda for Tumor Mutational Burden-High Cancer
The accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts of patients with various previously treated unresectable or metastatic solid tumors with TMB-H who were enrolled in the open-label phase 2 KEYNOTE-158 trial.
