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FDA Approves Fixed-Dose Prostate Cancer Combination Treatment

The FDA approved the first fixed-dose combination of the PARP inhibitor niraparib and the androgen biosynthesis inhibitor abiraterone (Akeega) for metastatic BRCA-mutant castration-resistant prostate cancer (CRPC). The approval stipulates use of the dual-action tablet with prednisone in patients with metastatic BRCA-mutant CRPC confirmed by an FDA-approved diagnostic test. Eligible patients must have had prior bilateral […]

Adcetris Plus Chemo Effective in HIV-Related Hodgkin Lymphoma

Brentuximab vedotin (Adcetris) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) was effective for patients with HIV-related stages II-IV classical Hodgkin lymphoma (cHL), according to results from the phase I/II AMC-085 study. All 37 patients who completed therapy in the 41-patient trial achieved a complete response; at 2 years, the progression-free survival (PFS) rate reached […]

FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer

The FDA has approved the PARP inhibitor olaparib (Lynparza) in combination with abiraterone (Zytiga) for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), the agency announced Wednesday. Adult patients should be selected for the combination therapy — which is given with prednisone (or prednisolone) — based on an FDA-approved companion diagnostic test to detect deleterious or suspected […]

Post-Immunotherapy Combo Promising in Advanced RCC

Combination treatment with a hypoxia-inducible factor (HIF) 2α inhibitor and tyrosine kinase inhibitor induced responses in nearly a third of advanced renal cell carcinoma (RCC) patients previously treated with immunotherapy, a single-arm phase II study found. In the study of 52 patients, 30.8% (95% CI 18.7-45.1) had a confirmed objective response following treatment with belzutifan […]

Sutezolid With 3-Drug Combo Appears Safe and Effective in Multidrug-Resistant TB

SEATTLE — Adding the oxazolidinone antibiotic sutezolid to a three-drug combination appeared to be safe and effective for people with multidrug-resistant tuberculosis (TB), according to a dose-finding phase II study. Across five treatment arms that included four different doses of sutezolid with bedaquiline, delamanid, and moxifloxacin at standard doses, there was a similar increase in […]

Novel Capsid Inhibitor Approved for Super-Refractory HIV

The FDA approved lenacapavir (Sunlenca) in combination with antiretroviral therapy (ART) for heavily pretreated HIV-1 patients with drug-resistant infections, and for those who cannot tolerate other available options. Lenacapavir, a first-in-class long-acting HIV capsid inhibitor, is initially administered via oral tablets (300 mg) and subcutaneous shots (463.5 mg/1.5 mL), which are then followed by maintenance […]

Durvalumab-CRT Pairing Disappoints in Locally Advanced Cervical Cancer

NEW YORK — An immunotherapy-chemoradiotherapy (CRT) combination did not boost progression-free survival (PFS) in untreated, locally advanced cervical cancer, according to CALLA trial findings. Newly diagnosed patients who received durvalumab (Imfinzi) plus standard CRT did not experience a statistically significant PFS improvement versus patients who received placebo plus CRT (hazard ratio 0.84, 95% CI 0.65-1.08, […]

Targeted Combo Flops as First-Line Treatment in Advanced Breast Cancer

PARIS — A novel combination failed to improve the clinical benefit rate (CBR) in advanced triple-negative breast cancer (TNBC) compared with chemoimmunotherapy, a randomized trial showed. Adding the anti-CD73 antibody oleclumab to durvalumab (Imfinzi) and chemotherapy led to clinical benefit (response plus stable disease) in 43% of patients by 24 weeks as compared with 44% […]

Rezvilutamide Bests Bicalutamide in Metastatic Prostate Cancer

In combination with androgen deprivation therapy (ADT), the novel androgen-receptor inhibitor rezvilutamide significantly improved radiographic progression-free survival (PFS) and overall survival (OS) compared with bicalutamide (Casodex) in patients with high-volume, metastatic, hormone-sensitive prostate cancer, the phase III CHART trial showed. Among 654 mostly Asian patients, median radiographic PFS was not reached in the rezvilutamide group […]

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