“To have achieved overall survival from this landmark study is highly encouraging and builds upon the positive pathological complete response and event-free survival results that led to approvals for this regimen around the world.” KEYN...
There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially ...
as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on
as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on
KEYNOTE: Creating Nanostructured Coatings to Improve Medical Device Performance while Obtaining Fast FDA ApprovalWebster, Thomas J
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urot... Pre-pembrolizumab neutrophil-to-lymphocyte ratio (NLR) predicts the efficacy of second-line pembroli... Profile of pembrolizumab in the treatment of patients with unresectable or metastatic urothelial...
Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma. Read More Behind the FDA Approval of Dato-DXd in HR+/HER2– Breast Cancer With Bardia Jordyn Sava;Aditya Bardia, MD, MPH ...
Behind the FDA Approval of Dato-DXd in HR+/HER2– Breast Cancer With Bardia Jordyn Sava;Aditya Bardia, MD, MPH February 7th 2025 Podcast In this episode of Targeted Talks, Aditya Bardia, MD, MPH, FASCO, discusses the recent FDA approval of datopotamab deruxtecan in breast cancer. Listen...
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with ad...
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical ...