Drug Approvals

The FDA has granted full approval to the cell therapy afamitresgene autoleucel (Tecelra) for adults and children aged 12 years and older with unresectable or metastatic synovial sarcoma. The approval expands on the drug’s accelerated approval in August 2024 by adding adolescent patients to the eligible population. The treatment is intended for patients whose cancer […]

China has approved satricabtagene autoleucel (satri-cel), making it the first CAR T-cell therapy in the world approved for the treatment of solid tumors. The therapy is intended for patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer whose disease has progressed after at least two previous treatments. The approval is based on results from

The FDA has approved capivasertib (Truqap) in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic hormone-sensitive prostate cancer. The agency also approved a companion diagnostic test to identify PTEN deficiency, a genetic alteration linked to more aggressive disease and found in about 25% of prostate cancer cases. The approval is based on results

The FDA has approved belzutifan (Welireg) in combination with pembrolizumab (Keytruda) for adults with clear cell renal cell carcinoma (ccRCC) who are at intermediate-high or high risk of recurrence after kidney cancer surgery. The approval is based on results from the phase 3 LITESPARK-022 trial, which enrolled 1,841 patients. The study compared belzutifan plus pembrolizumab

The European Union has approved a subcutaneous version of Sarclisa (isatuximab) delivered through the CirCLIQ on-body injector, making it the first cancer therapy approved for wearable injector administration. The approval covers all of the drug’s existing EU indications for multiple myeloma, including newly diagnosed and relapsed or refractory disease. The decision was based on results

Sacituzumab govitecan, an FDA-approved drug for breast cancer, has shown encouraging results as a potential treatment for advanced uterine cancer in a Phase II clinical trial . The study included 50 patients whose disease had progressed after standard therapies. Researchers found that 70% of participants experienced some degree of tumor shrinkage, while 28% achieved a

The FDA has approved Pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer. The drug is the first CD123-targeting antibody-drug conjugate that can be started in an outpatient setting. It is administered intravenously every three weeks based on actual body weight. Approval was supported by results

The FDA has approved Durvalumab (Imfinzi) plus BCG for adults with BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC). The approval is based on the phase 3 POTOMAC trial, which compared durvalumab plus BCG against standard BCG therapy alone. The combination significantly improved disease-free survival, reducing the risk of recurrence or progression by 32% (HR 0.68; P

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