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.
The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.
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.
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.
The University of Texas MD Anderson Cancer Center and AmMax Bio, Inc. announced a worldwide exclusive license agreement and clinical trial agreement to develop and advance AmMax’s AMB-066 monoclonal antibody therapy as a first-in-class treatment option for patients with colorectal cancer and minimal residual disease as well as those with MRD in other solid tumors.
