Kelulusan FDA dalam Onkologi: April-Jun 2026

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During the second quarter of 2026, oncology approvals issued by the U. S. Food and Drug Administration expanded the treatment options available for patients with breast cancer, urinary cancers, prostate cancer, rare cancers, and hematologic malignancies. Keep reading to learn about these approved therapeutics and how each fits into the treatment landscape of its respective cancer type. Breast Cancer: First PROTAC, New ADC Indikasi, and More Almost 322,000 women are expected to be diagnosed with breast cancer this year, but thanks to advances in treatment and early detection, the relative five-year survival in recent years has been over 90%. Five approvals issued this quarter exemplify the progress that continues to be made against multiple subtypes of this disease, including a new treatment modality and the expanded use of antibody-drug conjugates (ADCs). HR-positive, HER2-negative Breast Cancer About 70% of breast cancers are hormone receptor (HR)-positive and human epidermal growth factor 2 (HER2)-negative. Patients with these cancers are typically treated with endocrine therapy to block estrogen’s cancer-promoting activity in various ways, such as by disrupting estrogen production, blocking estrogen from binding to the estrogen receptor (ER), or destabilizing the ER so that it is ultimately degraded. The latter class of endocrine therapy comprises the selective estrogen receptor degraders (SERDs) fulvestrant (Faslodex), imlunestrant (Inluriyo), and elacestrant (Orserdu). This quarter, the FDA approved a first-in-class therapeutic that degrades the ER through a different mechanism than SERDs. Vepdegestrant is an example of a proteolysis-targeting chimera (PROTAC), a type of small molecule that binds to its target—ER in this case—and brings it to an E3 ubiquitin ligase to actively induce target degradation. Vepdegestrant is the first PROTAC to receive FDA approval for any cancer type. The approval was based on clinical trial data reported at the San Antonio Breast Cancer Symposium (SABCS) 2025, which is co-organized by the American Association for Cancer Research (AACR). The results showed that among patients whose breast cancers had mutations in the ESR1 gene, which encodes the ER, those treated with vepdegestrant had significantly longer progression-free survival (PFS) than those treated with fulvestrant. With its approval, vepdegestrant joins imlunestrant and elacestrant as oral ER-degrading therapeutics approved for this patient population. HR-positive, HER2-positive Breast Cancer HR-positive breast cancer treated with endocrine therapies frequently become resistant to those treatments, in part due to CDK4/6 activity. Combining endocrine therapy with CDK4/6 inhibition helps overcome resistance, and this combination has been approved for patients with HR-positive, HER2-negative breast cancers. For patients whose cancers are positive for both HR and HER2, however, no such combination was previously available. This quarter, the FDA approved the first CDK4/6 inhibitor for HER2-positive breast cancers. Researchers first reported that adding palbociclib to maintenance therapy improved PFS in this patient population at SABCS 2024. The FDA approval of the regimen was based on updated PFS data from the trial. An ADC that delivers a cell-killing drug to HER2-expressing cells, trastuzumab deruxtecan (T-DXd, Enhertu) has been previously approved to treat metastatic, HER2-positive or HER2-low breast cancers. Two new indications approved this quarter mean that T-DXd treatment may now be used for early-stage cancers as well. Triple-negative Breast Cancer Until recently, the standard first-line treatment available for patients with unresectable or metastatic triple-negative breast cancer (TNBC) was chemotherapy. This is because TNBC does not respond to hormone therapies and HER2-targeted therapies. Although the 2020 approval of the PD-1-targeted immunotherapy pembrolizumab (Keytruda) for metastatic TNBC provided a new first-line option for some patients, most patients with TNBC are ineligible for this therapy due to the lack of PD-L1 expression in their tumors. This quarter, the FDA approved two alternatives to first-line chemotherapy for patients with metastatic TNBC who are ineligible for PD-1/PD-L1-targeted immune checkpoint inhibitors like pembrolizumab. Both are ADCs targeting the TROP2 protein that is overexpressed by many solid tumors, including TNBC. Learn more about the emerging role of ADCs as first-line treatment for TNBC in this prior blog post that features perspectives from leading breast cancer experts who discussed TNBC treatment advances at SABCS 2025. Urinary Cancers: New Systemic Options for Bladder and Kidney Cancers This past quarter, the FDA greenlit three treatments for cancers arising in the urinary system, a network that produces, stores, and transports urine. For bladder cancer, two immune checkpoint inhibitors were approved: The FDA also approved a treatment for certain patients with kidney cancer: Prostate Cancer: Targeted Therapy for Metastatic Castration-sensitive Disease In the United States, one out of every eight men will be diagnosed with prostate cancer during their lifetime. Fortunately, most cases are diagnosed at early stages, when the cancer is more easily treated, but nearly 10% of cases are diagnosed after their prostate cancer has already metastasized. For these metastatic cases, hormone therapy has long been the mainstay of treatment. An approval issued this past quarter offers a new, more targeted option. Capivasertib is an inhibitor of AKT, a signaling protein that promotes tumor growth. PTEN is an upstream protein that normally keeps AKT activity in check, but in PTEN-deficient cancers, AKT remains active and drives cancer progression. Rare Cancers: Targeted Treatments Expand Options Patients with rare cancers often face limited treatment options, but FDA approvals issued this past quarter are expanding options for these patients. Afamitresgene autoleucel was the first approved T-cell receptor (TCR) T-cell therapy, a type of cellular immunotherapy in which patients’ T cells are harvested, engineered to better fight their tumor, and infused back into the patient’s body. It was also the first cellular immunotherapy approved for synovial sarcoma. The therapeutic targets MAGE-A4, which is expressed by many tumors, including synovial sarcomas. Only certain HLA proteins can present MAGE-A4, so afamitresgene autoleucel is approved only for patients who have such an HLA. Leukemia and Lymphoma: A Second-generation Inhibitor and Oral Chemotherapy