FDA has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
FDA has granted Fast Track designation to selinexor, Karyopharm Therapeutics Inc.'s first in class, oral SINE compound, for the treatment of patients with diffuse large B-cell lymphoma who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy.
Seattle Genetics Inc. has submitted a supplemental Biologics License Application to FDA based on data from the phase III ECHELON-2 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
Bristol-Myers Squibb Co. and Infinity Pharmaceuticals Inc. announced a clinical trial collaboration to evaluate Bristol-Myers Squibb's Opdivo (nivolumab) in combination with Infinity's IPI-549 in patients with advanced urothelial cancer.
ASCO and the Society for Immunotherapy of Cancer released a joint statement with twelve clinical trial reporting recommendations that address the unique efficacy, toxicity, and combination/sequencing aspects of immuno-oncology treatments.
Sandoz, a Novartis division focused on biosimilars, announced that it will not pursue its submission for biosimilar rituximab in the US at this time.
FDA has announced the availability of the MyStudies app, a mobile technology intended to foster the collection of real world evidence via patients' mobile devices.
Elsevier will integrate the National Comprehensive Cancer Network's Clinical Practice Guidelines in Oncology and utilize the NCCN Chemotherapy Order Templates as a reference into Via Oncology's Via Portal to provide clinical decision support at point of care and NCCN Guidelines concordance reporting.
Merck, known as MSD outside the United States and Canada, announced the FDA has approved Keytruda, Merck's anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer based on results from the KEYNOTE-407 trial.
Taiho Oncology, Inc. announced the FDA has accepted and granted priority review for the supplemental New Drug Application for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.
