FDA granted Breakthrough Therapy designation to Hernexeos (zongertinib tablets) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations.
FDA has granted Fast Track designation to CER-1236 for Acute Myeloid Leukemia. CER-1236 is a therapy that engineers a cancer patient’s own T-cell therapeutics that deploy phagocytic mechanisms alongside the array of built-in target cell destroying mechanisms used by T-cells.
The FDA’s Oncology Center of Excellence is inviting academic and patient advocate researchers to propose research questions for Project Collaborate, a crowdsourcing initiative running Sept. 2-26.
FDA has approved an expanded indication of the intravenous formulation of Avtozma (tocilizumab-anoh) to include the treatment of cytokine release syndrome in adults and pediatric patients aged two years and older.
The FDA has granted Breakthrough Therapy Designation to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha-directed, TOPO1-inhibitor antibody-drug conjugate, for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
The European Commission has granted marketing authorization for Ogsiveo (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing desmoid tumors who require systemic treatment. OGSIVEO is the first and only therapy approved in the European Union to treat desmoid tumors.
ColoAlert, a non-invasive colorectal cancer screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices. The test is designed to detect CRC tumor DNA and other biomarkers with high sensitivity in stool samples.
FDA granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients (1 year of age and older) with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
Imfinzi (durvalumab) has been accepted and granted Priority Review by the FDA for the treatment of patients with resectable, early-stage, and locally advanced (stages 2, 3, 4a) gastric and gastroesophageal junction cancers.
The European Commission approved Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone for the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
