The Ibex Medical Analytics Galen platform has received Breakthrough Device Designation from FDA.
The Breast International Group, the European Organization for Research and Treatment of Cancer and the Alliance Foundation Trials groups are collaborating with Sanofi to initiate a pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting.
Truseltiq (Infigratinib) a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.
FDA has granted accelerated approval to Lumakras (sotorasib) a RAS GTPase family inhibitor, for adult patients with KRAS G12C ‑mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA ‑approved test, who have received at least one prior systemic therapy.
The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma.
FDA has approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
FDA has approved Pylarify, an F 18-labeled prostate-specific membrane antigen targeted positron emission tomography imaging agent to identify suspected metastasis or recurrence of prostate cancer.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency as adopted a positive opinion recommending approval of Keytruda in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
The European Commission has approved Venclyxto (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
