Drug Approvals

The FDA has granted Priority Review to new applications for belzutifan (Welireg) combined with Pembrolizumab (Keytruda). A decision is expected by June 19, 2026. The application is based on results from the Phase 3 LITESPARK-022 study. The trial included 1,841 patients with clear cell renal cell carcinoma (ccRCC) at high risk of recurrence after kidney surgery. Patients […]

The U.S. Food and Drug Administration has granted Priority Review to the New Drug Application for rusfertide, a potential new treatment for adults with polycythemia vera (PV). A final approval decision is expected in the third quarter of 2026. PV causes the body to produce too many red blood cells, which thickens the blood and

Results show that adding Welireg (belzutifan) to Keytruda after surgery significantly lowers the risk of cancer coming back in patients with clear cell renal cell carcinoma. The study found that the combination reduced the risk of recurrence or death by 28% compared with Keytruda alone. After 24 months, 81% of patients who received both drugs

Results from the phase 3 LITESPARK-022 trial show that adding belzutifan (Welireg) to pembrolizumab (Keytruda) significantly improves outcomes for patients with clear cell renal cell carcinoma (ccRCC) who are at high risk of recurrence after kidney removal surgery. The combination reduced the risk of cancer returning or death by 28% compared with pembrolizumab alone. At 30 months,

CELMoDs (Cereblon E3 Ligase Modulators) are a new generation of oral drugs for multiple myeloma that may replace older immunomodulatory drugs like lenalidomide and pomalidomide. Both types of drugs target the protein cereblon, but CELMoDs are more powerful. While older drugs mainly slow cancer cell growth, CELMoDs directly trigger cancer cell death. They more effectively

The Phase 2 RC48G001 study evaluated disitamab vedotin in patients with advanced urothelial (bladder) cancer. Disitamab vedotin is an antibody-drug conjugate that targets the HER2 protein on cancer cells. After attaching to HER2, it enters the cell and releases a chemotherapy drug (MMAE) that kills the cancer cell from inside. The study included patients with

The FDA has granted full approval to encorafenib (Braftovi) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy (mFOLFOX6 or FOLFIRI) for adults with metastatic colorectal cancer that carries the BRAF V600E mutation. This decision upgrades an earlier accelerated approval to a standard treatment based on strong survival results. The approval is based on the phase

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to amivantamab plus hyaluronidase-lpuj (Rybrevant Faspro), a subcutaneous treatment for adults with recurrent or metastatic, HPV-unrelated head and neck squamous cell carcinoma (HNSCC) whose disease has worsened after platinum-based chemotherapy and immunotherapy. This designation is based on results from the Phase 1b/2 OrigAMI-4 study.

A new study shows that luspatercept-aamt (Reblozyl) is effective and safe for treating anemia in transfusion-dependent, lower-risk Myelodysplastic Syndromes (MDS). About 50% of patients achieved at least eight weeks without needing red blood cell transfusions. Certain groups benefited more. Patients who were ring sideroblast (RS)–positive had higher response rates than RS-negative patients, and those with

The U.S. Food and Drug Administration has approved a new all-oral treatment combination of acalabrutinib (Calquence) and venetoclax (Venclexta) for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is the first fixed-duration treatment in the U.S. that combines a BTK inhibitor with venetoclax, meaning patients can complete therapy in a set