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... […]
CDC recommended that 11-to-12-year-olds receive two doses of HPV vaccine at least six months apart rather than the previously recommended three doses to protect against cancers caused by human papillomavirus infections. Teens and young adults who start the series later, at ages 15 through 26 years, will continue to need three doses of HPV vaccine... […]
ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate, nal-IRI) in combination with 5-fluorouracil and leucovorin for the treatment of metastatic adenocarcinoma of the pancreas in patients who have progressed following gemcitabine based therapy received a marketing authorization from The European Commission. The agent is sponsored by Shire. Wth this approval, Shire is authorized to market Onivyde in... […]
VENCLYXTO (venetoclax) was granted a positive opinion from the European Committee for Medicinal Products for Human Use for the treatment of chronic lymphocytic leukemia in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in... […]
TECENTRIQ (atezolizumab) received FDA approval for the treatment of people with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. The agent is sponsored by Genentech, a member of the Roche Group.... […]
GENENTECH, a member of the Roche Group, received a second Breakthrough Therapy Designation from FDA for its anaplastic lymphoma kinase inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer who have not received prior treatment with an ALK inhibitor.
