CheckMate -8HW Trial Data Show Survival Improvement With Opdivo, Yervoy Combo in Colorectal Cancer
January 22nd 2024Opdivo (nivolumab) with Yervoy (ipilimumab) improved progression-free survival in patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.
Balversa Approved by FDA for FGFR3+ Urothelial Carcinoma
January 19th 2024Balversa (erdafitinib) is a fibroblast growth factor inhibitor granted accelerated approval by the FDA in April 2019 for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.
Phase III Trial Data Show Significant Progression-Free Survival Benefit With Lutathera for GEP-NETs
January 19th 2024Data from the NETTER-2 trial show that first-line treatment with Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with advanced gastroenteropancreatic neuroendocrine tumors.
Novocure Files for PMA Based on Positive Phase III Trial Data for TTFields Therapy for Lung Cancer
January 19th 2024The Phase III LUNAR trial (NCT02973789) is evaluating the addition of tumor-treating fields to standard-of-care therapies in patients with non-small cell lung cancer following disease progression on or after platinum-based treatment.
HyQvia Approved by FDA to Prevent Chronic Inflammatory Demyelinating Polyneuropathy Relapse
January 17th 2024Findings from ADVANCE-CIDP 1 and ADVANCE-CIDP 3 trials lead to FDA approval for HyQvia as a maintenance therapy to protect against relapse of neuromuscular disability and impairment in adult patients with chronic inflammatory demyelinating polyneuropathy.
FDA Fast Tracks Ovarian Cancer Drug Currently in Phase II Trial
January 12th 2024An open-label, randomized, dose-optimization Phase II trial (NCT06173037) is assessing the antibody-drug conjugate RC88 to determine the optimal dosage, efficacy, and safety in patients with platinum-resistant ovarian cancer.
FDA Priority Review Granted to Tivdak for Cervical Cancer Based on Phase III innovaTV 301 Trial Data
January 9th 2024Findings from the Phase III innovaTV 301 trial showed a favorable benefit/risk profile for Tivdak (tisotumab vedotin-tftv), as well as improved overall survival for patients with recurrent and metastatic cervical cancer who have limited treatment options.