The FDA has approved Lyrfigtu (lirafugratinib) as a second-line treatment for cholangiocarcinoma (bile duct cancer) with FGFR2 fusion or other rearrangements. The drug demonstrated a 46% confirmed objective response rate and median duration of response of 11.8 months in clinical trials.
Mayo Clinic and Thermo Fisher Scientific are forming a new company called Precure to generate population-scale molecular data that will inform the development of diagnostics, therapies, and other healthcare products.
Eli Lilly's imlunestrant/abemaciclib combination has received approval for treating ESR1-mutated breast cancer. The key distinction from AstraZeneca's competing camizestrant/anti-CDK 4/6 therapy is the timing of endocrine therapy switching.
Researchers at Dana-Farber Cancer Institute and 23andMe Research Institute have identified a rare inherited mutation in the Epidermal Growth Factor Receptor (EGFR) gene that increases lung cancer risk by 25-fold, helping explain why 10-20% of U.S. lung cancer cases occur in people who never smoked.
The US Food and Drug Administration has granted expanded accelerated approval for sevabertinib as a frontline treatment option for patients with HER2-mutant advanced non-small cell lung cancer, with nursing management focusing on diarrhea monitoring.
Researchers at Vanderbilt Health have published findings in Nature Cardiovascular Research showing that spatial transcriptomics of cardiac biopsies reveals significant cellular and molecular variation in transplant rejection that is not captured by conventional biopsy grading, potentially enabling precision medicine approaches to organ rejection treatment.
New studies identify genetic mutations underlying inherited bone marrow failure syndromes and demonstrate that non-driver mutations in myeloproliferative neoplasms like essential thrombocythemia and polycythemia vera have predictive value for patient outcomes.
The FDA has approved Novartis' radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in combination with hormone therapy for patients with PSMA-positive metastatic prostate cancer who are still hormone-sensitive, nearly doubling the eligible patient population from its previous indication for hormone-resistant cases.
New research analyzing patients from Kite Pharma's Yescarta clinical trials has identified inherited genetic signatures that can predict which patients are at higher risk for toxic side effects from CAR-T cell therapy, potentially enabling better patient selection and monitoring for this cancer immunotherapy.
The European Commission has approved AstraZeneca's Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for first-line treatment of adults with ER-positive, HER2-negative advanced breast cancer with emergent ESR1 mutations. The approval is based on SERENA-6 Phase III trial results showing a 56% reduction in risk of disease progression or death.
The Advanced Research Projects Agency for Health (ARPA-H) has launched a $160 million initiative to fund seven groups over five years to develop custom gene editing drugs, aiming to replicate successes like the Baby KJ case.
The U.S. FDA has approved Orca Bio's TREGZI, the first precision-engineered cell therapy for allogeneic transplants in adults with hematological malignancies, designed to reduce stem cell transplant complications.
Scientists have developed a DNA test that can distinguish between breast cancer patients who are likely to benefit from chemotherapy and those who can safely avoid it, potentially sparing millions from unnecessary treatment.
Setidegrasib, an investigational targeted therapy drug, demonstrated ability to slow cancer growth and shrink tumors in a first-in-human clinical trial published in the New England Journal of Medicine, targeting a previously difficult-to-treat cancer mutation.
Revolution Medicines presented new positive clinical trial data at AACR for its KRAS-targeting drug in pancreatic cancer patients, building on previously reported breakthrough survival results and expanding evidence for a novel class of treatments beyond current KRAS inhibitors.
