Paige launched an AI medical device software called Paige Breast Lymph Node that helps pathologists detect if breast cancer has metastasized to lymph nodes, concurrent with pathologists’ own interpretive review.
FDA approved Opdualag (nivolumab and relatlimab-rmbw) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.
FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
PathAI and Cleveland Clinic announced a five-year strategic collaboration leveraging PathAI’s quantitative pathology algorithms to conduct translational research and to use as clinical diagnostics in multiple disease areas.
FDA has approved for FoundationOne CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors approved by FDA for this indication.
Strata Oncology Inc. announced enrollment of the first patient in the Strata Sentinel trial, a prospective, observational study that will evaluate the ability of the investigational StrataMRD test to detect cancer recurrence in advance of standard of care techniques across solid tumors, as well as the clinical benefit of treatment in early-stage patients who are or become ctDNA-positive after surgery or other therapy with curative intent.
FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer in the neoadjuvant setting.
FDA accepted a supplemental New Drug Application for Tibsovo (ivosidenib tablets) as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia. The sNDA was granted priority review.
FDA issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care (The Cancer Letter, Feb. 4, 2022).
Wednesday, March 8, marks six months since FDA failed to meet its court-ordered deadline to rule on all e-cigarette and other new tobacco product manufacturers’ applications.
