Drug Approvals

The FDA has approved pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer. The first-in-class antibody-drug conjugate targets CD123 and delivers a DNA-damaging payload directly to cancer cells. Approval was based on the Phase 1/2 CADENZA trial. In treatment-naive patients, the complete remission rate reached 69.7%, with a […]

The European Medicines Agency’s CHMP has recommended approval of Enhertu for adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors lacking satisfactory treatment options. If approved by the European Commission, it would become the first HER2-targeted tumor-agnostic antibody-drug conjugate available in the European Union. The recommendation is supported by phase 2 trials

The FDA-approved combination of Opdivo plus Yervoy is rapidly reshaping first-line treatment for advanced hepatocellular carcinoma (HCC). The April 2025 approval was based on results from the phase 3 CheckMate 9DW trial, which compared the immunotherapy combination against standard tyrosine kinase inhibitors, including Lenvima and Nexavar. The study showed the immunotherapy regimen improved median overall

The European Medicines Agency’s CHMP has recommended approval of camizestrant combined with a CDK4/6 inhibitor for patients with ER-positive, HER2-negative advanced breast cancer who develop ESR1 mutations before disease progression. The recommendation is based on results from the Phase 3 SERENA-6 trial, which used regular liquid biopsies to detect ESR1 mutations early. Patients who switched

The FDA has approved Datroway (datopotamab deruxtecan-dlnk, Dato-DXd) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on results from the phase 3 TROPION-Breast02 trial. Dato-DXd significantly improved outcomes compared with standard chemotherapy. Median overall survival reached 23.7 months versus 18.7 months

The U.S. Food and Drug Administration has approved Tecentriq and Tecentriq Hybreza as adjuvant treatments for patients with muscle-invasive bladder cancer who test positive for circulating tumor DNA (ctDNA) after bladder removal surgery. The approval is tied to the Signatera CDx companion diagnostic, marking a major step toward precision oncology. The decision was based on

On May 13, 2026, the FDA approved an all-oral combination of decitabine/cedazuridine (Inqovi) and venetoclax (Venclexta) for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or unable to receive intensive chemotherapy. The approval was based on results from the phase 2 ASCERTAIN-V trial involving 101 patients. The study showed

The U.S. Food and Drug Administration has granted accelerated approval to Sonrotoclax for adults with relapsed or refractory Mantle Cell Lymphoma who have already received at least two previous treatments, including a BTK inhibitor. The approval was based on results from the BGB-11417-201 trial involving 103 patients whose disease had returned after standard therapies. The

The FDA has approved Zenocutuzumab (Bizengri) for adults with advanced bile duct cancer linked to rare $NRG1$ gene fusions after previous treatments stopped working. The approval gives a new option to patients with this ultra-rare form of cholangiocarcinoma, a cancer that usually has very limited treatment choices. The decision was based on results from the

The U.S. Food and Drug Administration has authorized an expanded access program for daraxonrasib, an experimental treatment for patients with previously treated metastatic pancreatic cancer. The decision follows strong results from the Phase 3 RASolute 302 trial. The study showed that daraxonrasib significantly improved survival compared with standard chemotherapy. The drug reduced the risk of