FDA approved Ensacove (ensartinib) for adult patients with anaplastic lymphoma kinase-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.
FDA approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).
FDA approved Unloxcyt (osibelimab-ipdl), a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
FDA approved Ryoncil (remestemcel-L-rknd), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients two months of age and older. Ryoncil is the first FDA-approved MSC therapy.
FDA approved Opdivo (nivolumab) and Opdivo Qvantig (hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
FDA cleared an investigational new drug application for a phase I/II clinical trial of REC-4539, a brain penetrant LSD1 inhibitor. Initial clinical investigation will focus on small cell lung cancer while also exploring several other solid tumor indications.Â
Robert F. Kennedy Jr., President-elect Donald Trump’s choice for HHS secretary, is unfit for that role and should not be confirmed, 77 Nobel laureates said in a letter to members of the U.S. Senate.
FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
FDA has granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults
