October 16th 2024
Results from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus standard-of-care achieved sustained disease control.
FDA to Evaluate BLA for Datopotamab Deruxtecan in Non-Small Cell Lung Cancer
February 20th 2024The FDA set a Prescription Drug User Fee Act date during Q4 of 2024 for the biologics license application for datopotamab deruxtecan in patients with previously treated advanced nonsquamous non-small cell lung cancer.
Bristol Myers Squibb Seeks Approval for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
February 7th 2024Results from the Phase III CheckMate -77T trial show that Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo produced statistically significant and clinically meaningful improvements in event-free survival in patients with resectable stage IIA to IIIB non-small cell lung cancer.
GSK's Blenrep Produces Significant Survival Improvement in Relapsed or Refractory Multiple Myeloma
February 6th 2024Patients with relapsed or refractory multiple myeloma administered Blenrep combined with bortezomib plus dexamethasone experienced a 59% reduction in the risk of disease progression or death compared with the standard of care.
FDA Fast Tracks Antibody-Drug Conjugate for Ovarian, Fallopian Tube, Primary Peritoneal Cancers
February 6th 2024BioNTech SE and Duality Biologics' next-generation antibody-drug conjugate is being evaluated for patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
Astellas Announces Submission of sNDA for Padcev/Keytruda Combo for Urothelial Cancer
January 31st 2024Approval sought for Padcev (enfortumab vedotin) plus Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer, which would be the first approved combination alternative to platinum-containing chemotherapy for this patient population.