The European Medicines Agency has validated its Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer.
FDA has finalized a rule to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.
FDA issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors-1, -2, and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer.
FDA has approved ImmunityBio’s Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin for the treatment of patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
Health Canada approved Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The European Commission has approved a label extension for Astellas Pharma’s Xtandi (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer who are unsuitable for salvage-radiotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Bristol Myers Squibb's Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
FDA revised a draft guidance to answer questions that biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars.
FDA approved Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test.