In 1999, Richard Pazdur, a GI oncologist at MD Anderson, saw an FDA recruitment ad in The New England Journal of Medicine. The agency was looking for a director of the FDA Division of Oncology Drug Products.
Colorectal cancer is the second leading cause of cancer-related death in the United States. Accurate and early detection of CRC and precancerous lesions is critical for reducing incidence and preventing deaths from this disease.
FDA issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.
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.
