FDA Grants Priority Review to Lirafugratinib for FGFR2-Positive Cholangiocarcinoma

Drug Approvals /

The U.S. Food and Drug Administration has granted Priority Review to lirafugratinib, an oral FGFR2 inhibitor, for patients with pretreated cholangiocarcinoma carrying FGFR2 fusions or rearrangements. A regulatory decision is expected by September 27, 2026. In the Phase 1/2 ReFocus trial, 114 FGFR inhibitor–naive patients showed a 46.5% objective response rate, including 2.6% complete responses, […]

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FDA Approves Ponlimsi, Expanding Biosimilar Options for Osteoporosis Treatment

Drug Approvals /

The U.S. Food and Drug Administration approved denosumab-adet as a biosimilar to denosumab, expanding treatment options for osteoporosis and bone loss. The drug is approved for all the same uses as Prolia, including treating osteoporosis in high-risk men and postmenopausal women, managing bone loss caused by long-term steroid use, and increasing bone mass in patients

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CML Treatment Advances Expand Options and Improve Long-Term Outcomes in 2026

Treatment /

Treatment for chronic myeloid leukemia is rapidly advancing in 2026, offering patients more effective and flexible options than ever before, according to Michael J. Mauro. A new generic version of dasatinib marks a key step forward, as it can be taken with common acid-reducing drugs, simplifying treatment for patients with reflux. Other updates include improved

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FDA and Global Advances Drive Momentum in Gastrointestinal Cancer Therapies

Treatment /

The FDA approved the PD-L1 IHC 22C3 pharmDx test as a companion diagnostic to help identify patients who may benefit from pembrolizumab. In liver cancer, a new antibody called RCT1213 received Orphan Drug Designation for patients with hepatocellular carcinoma who no longer respond to checkpoint inhibitors, highlighting efforts to target the tumor microenvironment. Progress also

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Bladder Cancer Implant TAR-210 Shows Promising Safety and Efficacy in Early Trial

Clinical Trails /

Results from a Phase 1 study show that Erda-iDRS (TAR-210), a new drug-delivery system placed directly into the bladder, appears to be both safe and effective for patients with FGFR-altered non–muscle-invasive bladder cancer. In high-risk patients, the treatment kept cancer from coming back for a median of 20 months, with 83% of patients remaining recurrence-free

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Implantable Enzalutamide Therapy Shows Safety and Early Promise in Prostate Cancer Trial

Clinical Trails /

A new early-phase clinical trial suggests that Enolen, a novel implant designed to deliver the prostate cancer drug enzalutamide directly into tumors, is both safe and practical for patients with early-stage disease. Researchers reported that no serious side effects above grade 3 were linked to either the implant procedure or the drug itself. Most patients

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Dinaciclib Targets Survival Pathways in Aggressive Adult T-Cell Leukemia/Lymphoma

Targeted Therapy /

A new study highlights dinaciclib as a promising treatment for Adult T-cell Leukemia/Lymphoma, an aggressive cancer caused by the Human T-lymphotropic Virus 1 with very poor survival outcomes. Researchers found that ATL cells rely heavily on anti-apoptotic proteins to avoid cell death, largely driven by viral proteins that keep these survival pathways active. Dinaciclib works by

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Bortezomib Shows Promise in Overcoming Immunotherapy Resistance in Lung Cancer

Immunotherapy /

A new study shows that bortezomib, a drug used for Multiple Myeloma, may help overcome resistance to immunotherapy in Non-Small Cell Lung Cancer. Researchers found the drug prevents the breakdown of the interferon-gamma receptor (IFNGR1), a key molecule tumors often destroy to avoid immune detection. By preserving this receptor, cancer cells become more visible and

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IMNN-001 Immunotherapy Boosts Survival in Advanced Ovarian Cancer

Immunotherapy /

Final results from the Phase 2 OVATION 2 trial show that adding IMNN-001 to standard chemotherapy significantly improves survival for women with newly diagnosed advanced ovarian cancer. The study found that median overall survival increased by 14.7 months with IMNN-001 plus chemotherapy compared to chemotherapy alone (45.1 vs. 30.4 months). For patients who also received

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Atezolizumab Plus Chemotherapy Cuts Recurrence Risk in Stage III dMMR Colon Cancer

Treatment /

Results from the Phase 3 ATOMIC trial show that adding atezolizumab to standard chemotherapy significantly lowers the risk of recurrence in patients with resected stage III colon cancer that has deficient DNA mismatch repair (dMMR). The study found that combining atezolizumab with FOLFOX chemotherapy cut the risk of cancer returning or death by half. Three-year disease-free

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