FDA Clears Welireg and Lenvima Combination for Advanced Clear Cell Kidney Cancer After Immunotherapy
The US Food and Drug Administration has approved a new all-oral treatment combination for adults with advanced kidney cancer whose disease has already been treated with PD-1 or PD-L1 immunotherapy. The regimen combines Welireg with Lenvima for renal cell carcinoma containing a clear cell component. The decision provides another treatment option for patients whose cancer has progressed after immune checkpoint therapy. It is also the first FDA-approved regimen to combine an HIF
5 hours ago2 min read
FDA Clears AstraZeneca's Etcamah for a Genetically Defined Subset of First-Line Breast Cancer | iPharmaCenter
The Food and Drug Administration granted accelerated approval to Etcamah, known scientifically as camizestrant, for use alongside any of three widely used CDK4/6 inhibitors in adult patients whose tumors carry a particular genetic change called an ESR1 mutation. Why This Approval Matters Breast cancer remains the most frequently diagnosed malignancy among women in the United States, with more than 300,000 new cases identified each year and over 42,000 deaths. The majority of
Sep 54 min read
Ionis Wins First Ever FDA Approval for an Alexander Disease Treatment, Marking a Turning Point for a Disease With No Prior Options
Regulators in the United States have given the green light to a new spinal injection therapy built to slow one of the rarest and most devastating disorders of the nervous system, handing patients and families their first real treatment option after decades with none. The Food and Drug Administration cleared Zanvastro, known by its scientific name zilganersen, for use in both children and adults living with Alexander disease, a genetic condition so uncommon that it touches rou
Sep 43 min read
FDA Approves Takeda’s MIMRYLO for Polycythemia Vera | iPharmaCenter
The U.S. Food and Drug Administration has approved MIMRYLO, also known as rusfertide, for the treatment of erythrocytosis in adults with polycythemia vera, a rare and chronic blood cancer. The decision introduces the first hepcidin mimetic medicine authorized for this condition, offering patients a new mechanism of action beyond the therapies currently available. A Long-Standing Challenge in PV Management Polycythemia vera affects an estimated 90,000 people in the United Stat
Aug 303 min read
FDA Approves Revolution Medicines’ RASONQUE for Metastatic Pancreatic Cancer | iPharmaCenter
The U.S. Food and Drug Administration has approved RASONQUE, also known as daraxonrasib, as a once-daily oral treatment for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent chemotherapy. The decision marks the first approval of a broad RAS-targeted medicine for this disease. RASONQUE belongs to a new class of RAS(ON) multi-selective and mutant-selective inhibitors designed to suppre
Aug 273 min read