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.
ABBVIE said Health Canada has issued a Notice of Compliance with Conditions for Venclexta (venetoclax). The therapy has been approved for previously treated chronic lymphocytic leukemia patients, who have either a genetic mutation, known as 17p deletion, or no other available treatment options. Under NOC/c policy, AbbVie will provide Health Canada with data from additional... […]
FOUNDATION MEDICINE, INC. announced the addition of new clinical markers to its FoundationOne and FoundationOne Heme products, which are designed to enhance oncologists’ insight into potential response to immunotherapies. This ability to determine TMB and MSI from its assays is additional to the existing comprehensive profiling of genes provided by FoundationOne and FoundationOne Heme. Taken... […]
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.
THE US ONCOLOGY NETWORK selected Myriad Genetics as its preferred provider laboratory for hereditary cancer testing. As part of the collaboration, Myriad and The US Oncology Network will work together to perform hereditary cancer research through the Genetic Risk Evaluation and Testing program within The Network affiliated practices. Under this program, the two organizations will... […]
GAMIDA CELL said FDA has granted Breakthrough Therapy Designation to the company’s lead product candidate, NiCord, in development as a novel graft modality for bone marrow transplantation in patients with high risk hematological malignancies. The international, multi-center phase III registration study of NiCord is planned to begin before the end of the year, the company... […]
