FDA has granted an accelerated approval to Krazati (adagrasib), 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.
Pragmatica-Lung is shaping up as the clinical trial to watch—not just because of the research question, but because of the way it’s being addressed.
Pragmatica-Lung is the first of what is likely to be a series of simpler trials with relaxed enrollment criteria and streamlined data collection requirements.
The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research.
Patients with metastatic non-small cell lung cancer who are matched to targeted therapy live longer when liquid biopsies are used to detect genomic alterations in circulating tumor DNA that aren’t picked up by tissue sequencing, according to a study published Nov. 10 in Nature Medicine.
FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
FDA has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing EGFR mutation or anaplastic lymphoma kinase genomic tumor aberrations.
Portage Biotech Inc., a clinical-stage immuno-oncology company focused on overcoming cancer treatment resistance, entered into an agreement with Merck.
The PERLA phase II trial met its primary endpoint of objective response rate by Response Evaluation Criteria in Solid Tumors criteria as determined by blinded independent central review. The trial evaluated Jemperli (dostarlimab) in combination with chemotherapy versus pembrolizumab in combination with chemotherapy in first-line patients with metastatic non-squamous NSCLC.
FDA has granted regular approval to Retevmo (selpercatinib) adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
