Eli Lilly and Company announced on September 25, 2025, that the U.S. Food and Drug Administration (FDA) has approved Inluriyo (imlunestrant), a 200 mg oral tablet, for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer (MBC). This approval targets patients whose disease has progressed following at least one line of endocrine therapy (ET), addressing a critical need as approximately 50% of ER+, HER2- MBC patients develop ESR1 mutations after aromatase inhibitor exposure, leading to treatment resistance.
On September 19, 2025, the U.S. Food and Drug Administration (FDA) approved Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use in adults across 38 solid tumor indications previously approved for KEYTRUDA® (pembrolizumab), marking it as the first subcutaneously administered immune checkpoint inhibitor.
Johnson & Johnson’s Innovative Medicine division marked a significant advancement in oncology on September 9, 2025, with the U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system), formerly known as TAR-200. This novel therapy targets adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) characterized by carcinoma in situ (CIS), with or without papillary tumors—conditions affecting about 10% of NMIBC cases and leaving patients with few bladder-sparing alternatives post-BCG failure. INLEXZO™ addresses a critical unmet need in a field stagnant for over four decades, offering a potential paradigm shift by enabling extended local chemotherapy delivery without the morbidity of radical cystectomy, which carries a 3-8% postoperative mortality risk and profoundly impacts quality of life, particularly among older patients.
Eli Lilly and Company’s Verzenio® (abemaciclib), a CDK4/6 inhibitor, has demonstrated significant improvement in overall survival (OS) in patients with hormone receptor-positive (HR+), HER2-negative (HER2-), node-positive, high-risk early breast cancer, as reported in the phase 3 monarchE trial. This global, randomized, open-label, multicenter study enrolled 5,637 patients across 600 sites in 38 countries, evaluating two years of Verzenio plus endocrine therapy (ET) against ET alone.
The study explores the action of amlodipine, a drug used commonly to treat hypertension, on lung cancer cells. Lung cancer is one of the leading causes of cancer-related deaths globally, and the currently available treatment strategies like chemotherapy are associated with critical side effects and diminish efficacy over time due to the emergence of chemoresistance.
The U.S. Food and Drug Administration (FDA) has given the green light to a new combination therapy for adults suffering from specific types of relapsed or hard-to-treat large B-cell lymphomas (LBCL) who are not suitable candidates for stem cell transplants or CAR-T therapy. This innovative treatment consists of brentuximab vedotin (Adcetris), lenalidomide, and rituximab (BV+R2). It specifically targets types of LBCL such as diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL that arises from slower-growing lymphoma.
