FDA granted 510(k) clearance to GE HealthCare’s MIM Software tool to calculate the absorbed dose of radionuclides using a Monte Carlo method.
FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent Opdivo after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
FDA granted traditional approval to Retevmo (selpercatinib) for adult and pediatric patients two years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.
FDA approved the Cologuard Plus test, a multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are at average risk for colorectal cancer.
FDA approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.
FDA approved Tagrisso (osimertinib) in the U.S. for treatment of adult patients with unresectable, stage 3 epidermal growth factor receptor-mutated non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy.
Bayer announced the submission of a supplemental new drug application to FDA for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
FDA has approved Keytruda in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.
FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
