This Issue's News and Views

NEWS & VIEWS ......

SEPTEMBER 10, 2018

FDA Approves Enzalutamide for Castration- Progression-Free Survival as Surrogate for Overall Resistant Prostate Cancer1 Survival in First-Line Treatment of DLBCL

On July 13, 2018, the US Food and Drug Administration (FDA) approved In an individual patient-level analysis reported in the enzalutamide (Xtandi) for patients with castration-resistant prostate Journal of Clinical Oncology, Shi et al6 found that progression-free cancer (CRPC). This approval broadens the indicated patient survival could serve as a surrogate endpoint for overall population to include patients with either nonmetastatic CRPC or survival in the first-line treatment of diffuse large B-cell lymphoma metastatic CRPC. Enzalutamide was previously approved for the (DLBCL). treatment of patients with metastatic CRPC. Brain Metastases in ROS1-Positive Lung Cancer and First-Line Treatment With Checkpoint Inhibitors in Treatment With Crizotinib Patients With Melanoma Brain Metastases A study published by Patil et al7 in the Journal of Thoracic Oncology An analysis of newly diagnosed patients with cutaneous melanoma explores the occurrence and treatment of brain metastases in stage brain metastases treated with checkpoint blockade immunotherapy IV ROS1-positive non–small cell lung cancer. has found that the treatment was associated with an increase in median overall survival. The benefit was even more pronounced in FDA Approves Ivosidenib for IDH1-Mutated AML8 patients with melanoma brain metastases without extracranial metastases. The study by Iorgulescu et al2 was published in Cancer Today, the US Food and Drug Administration (FDA) approved Immunology Research. ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have fi fi Addition of Systemic Therapy to Involved-Field a speci c genetic mutation. This is the rst drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion Radiotherapy in Early-Stage Follicular Lymphoma diagnostic used to detect specific mutations in the IDH1 gene in Results of the phase III Trans-Tasman Radiation Oncology Group patients with AML. 99.03 trial reported in the Journal of Clinical Oncology by MacManus et al3 indicate that use of systemic therapy following involved-field REFERENCES radiotherapy increased progression-free survival in patients with fi stage I or II low-grade follicular lymphoma. 1. ClinicalTrials.gov: Safety and ef cacy study of enzalutamide in patients with nonmetastatic castration-resistant prostate cancer (PROSPER). https:// clinicaltrials.gov/ct2/show/NCT02003924?term5PROSPER&cond5prostate1 FDA Expands Ribociclib Indication in Hormone cancer&rank51 Receptor–Positive, HER2-Negative Advanced or 2. Iorgulescu JB, Harary M, Zogg CK, et al: Improved risk-adjusted survival 4 for melanoma brain metastases in the era of checkpoint blockade immuno- Metastatic Breast Cancer therapies: Results from a national cohort. Canc Immunol Res 10.1158/2326- 6066.CIR-18-0067 Today, the US Food and Drug Administration (FDA) expanded the 3. MacManus M, Fisher R, Roos D, et al: Randomized trial of systemic indication for ribociclib (Kisqali) in combination with an aromatase therapy after involved-field radiotherapy in patients with early-stage follicular inhibitor for premenopausal or perimenopausal women with hormone lymphoma: TROG 99.03. J Clin Oncol 10.1200/JCO.2018.77.9892 receptor–positive, HER2-negative advanced or metastatic breast 4. ClinicalTrials.gov: Study of efficacy and safety in premenopausal women cancer as initial endocrine-based therapy. The FDA also approved with hormone receptor positive, HER2-negative advanced breast cancer (MONALEESA-7). https://clinicaltrials.gov/ct2/show/NCT02278120?term5 ribociclib in combination with fulvestrant for postmenopausal women NCT02278120&rank51 with hormone receptor–positive, HER2-negative advanced or 5. Abou-Alfa GK, Meyer T, Cheng A-L, et al: Cabozantinib in patients with metastatic breast cancer as initial endocrine-based therapy or advanced and progressing hepatocellular carcinoma. N Engl J Med 379:54–63, following disease progression on endocrine therapy. 2018 6. Shi Q, Schmitz N, Ou F-S, et al: Progression-free survival as a surrogate end point for overall survival in first-line diffuse large B-cell lymphoma: An Cabozantinib vs Placebo in Advanced Hepatocellular individual patient–level analysis of multiple randomized trials (SEAL). J Clin Carcinoma Previously Treated With Sorafenib Oncol 10.1200/JCO.2018.77.9124 7. Patil T, Smith DE, Bunn PA, et al: The incidence of brain metastases in As reported in The New England Journal of Medicine by Abou-Alfa stage IV ROS1-rearranged non-small cell lung cancer and rate of central et al,5 the second interim analysis of the phase III CELESTIAL trial has nervous system progression on crizotinib. J Thorac Oncol doi: https://doi.org/ 10.1016/j.jtho.2018.07.001 shown a significant improvement in overall and progression-free 8. ClincalTrials.gov: Study of orally administered AG-120 in subjects survival with cabozantinib vs placebo in patients with sorafenib- with advanced hematologic malignancies with an IDH1 mutation. https:// treated advanced hepatocellular carcinoma. clinicaltrials.gov/ct2/show/NCT02074839?term5NCT02074839&rank51