Regeneron Pharmaceuticals Inc. and Inovio Pharmaceuticals Inc. announced a clinical study agreement for a Phase Ib/IIa immuno-oncology trial.
FDA granted accelerated approval to durvalumab (trade name Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Palmetto GBA, a Medicare administrative contractor that assesses molecular diagnostic technologies, has issued a draft local coverage determination for the Oncotype DXGenomic Prostate Score issued a draft LCD that recommends Medicare coverage for use of the test in qualified patients with favorable intermediate-risk prostate cancer.
The European Commission approved Opdivo (nivolumab) as monotherapy for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
FDA granted accelerated approval to Genentech's Tecentriq (atezolizumab) for the initial treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
FDA approved midostaurin, trade name Rydapt, for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive, as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
FDA expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade.
FDA granted an accelerated approval to brigatinib, trade name Alunbrig, for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
FDA has posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.
DelMar Pharmaceuticals Inc. said it has entered into a three-year collaboration with Duke University to evaluate VAL-083, the company's platform compound, as a front-line treatment for newly diagnosed patients with glioblastoma multiforme.