VENTANA ALK (D5F3) CDx Assay received FDA approval for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to aid in the identification of ALK-positive lung cancer patients who are eligible for treatment with Pfizer’s FDA-approved therapy Xalkori. VENTANA ALK (D5F3) CDx Assay is intended for laboratory use in... […]
LEE011 (ribociclib, a selective cyclin dependent kinase inhibitor developed by Novartis, was granted Priority Review by FDA. FDA also accepted Novartis’s new Drug Application for filing as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with letrozole. The NDA is based on... […]
VENTANA PD-L1 assay received FDA approval as a complementary diagnostic to identify PD-L1 expression levels in patients considering treatment with the FDA-approved Roche cancer immunotherapy Tecentriq (atezolizumab) for previously treated metastatic non-small cell lung cancer.
ALECENSARO (alectinib) received approval from Health Canada as a monotherapy for the treatment of patients with anaplastic lymphoma kinase-positive, locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. The drug is marketed under the name Alecensa in the US. The drug, which... […]
BRISTOL-MYERS SQUIBB was granted conditional approval by Health Canada for the treatment of previously untreated adults with unresectable or metastatic melanoma using Opdivo and Yervoy. The first-ever combination of two immuno-oncology agents has the potential to increase progression-free survival in certain patients. Health Canada also issued a Notice of Compliance with conditions for the OPDIVO... […]
XTANDI (enzalutamide) capsules received FDA approval for Supplemental New Drug Application to update the U.S product labeling. The drug is sponsored by Astellas Pharma Inc. and Pfizer Inc. The SNDA is based on new data from the TERRAIN study which indicated improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were... […]
KEYTRUDA (pembrolizumab) received FDA approval for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test.
YS-ON-001 was granted orphan drug designation by FDA for the treatment of hepatocellular carcinoma. YS-ON-001 is a promising biological product with immunomodulating effects, such as induction of anti-tumor cytokines, activation of NK cells, regulation of macrophage polarization, and suppression of regulatory T cells. YS-ON-001 is a clinical stage biological product based on proprietary immunomodulating cell... […]
LARTRUVO (olaratumab injection, 10 mg/mL) in combination with doxorubicin received an FDA accelerated approval for the treatment of adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery.
IBM WATSON HEALTH and Quest Diagnostics announced the launch of IBM Watson Genomics from Quest Diagnostics, a service that combines cognitive computing with genomic tumor sequencing. Memorial Sloan Kettering Cancer Center will supplement Watson’s corpus of scientific data with OncoKB, a precision oncology knowledge base to help inform precision treatment options for cancer patients. Watson’s... […]
