NEWS & VIEWS FEBRUARY 20, 2019

FDA Approves Olaparib for Maintenance Treatment of overall survival than gemcitabine in patients with resected pancreatic BRCA-Mutated, Advanced Ovarian Cancer cancer. Today, the US Food and Drug Administration1 (FDA) approved olaparib High Long-Term Risk of Solid Cancers in Survivors of (Lynparza) for the maintenance treatment of adult patients with Childhood Hodgkin deleterious or suspected deleterious germline or somatic BRCA-mutated A new study published by Holmqvist et al6 in the journal Cancer may advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer bolster existing evidence that survivors of childhood Hodgkin lymphoma fi who are in complete or partial response to rst-line platinum-based face an elevated risk of developing various types of solid tumors many . Patients with germline BRCA-mutated advanced years later. epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic, Lenalidomide Maintenance Versus Observation in Newly which was also approved today. Diagnosed Multiple Myeloma 7 FDA Approves for Merkel Cell Carcinoma In a UK phase III trial reported in The Lancet Oncology, Jackson et al found that lenalidomide maintenance was associated with improved The FDA2 also granted accelerated approval to pembrolizumab progression-free survival but not overall survival among patients with (Keytruda) for adult and pediatric patients with recurrent locally newly diagnosed multiple myeloma with at least minimal response to advanced or metastatic Merkel cell carcinoma. induction therapy. Potential overall survival benefits of lenalidomide were First-Line Ibrutinib With or Without Versus observed in some subgroups. Rituximab/Bendamustine in Older Patients With CLL Time to Biochemical Failure as Surrogate Endpoint in Locally In a phase III trial reported at the recent American Society of Hematology Advanced Prostate Cancer Annual Meeting and Exposition and in The New England Journal As reported in Journal of Clinical Oncology by Dignam et al,8 analysis of of Medicine by Woyach et al,3 ibrutinib and ibrutinib/rituximab outcomes in the phase III NRG/RTOG 9202 trial indicates that the time were associated with superior progression-free survival versus interval to biochemical failure could serve as a surrogate endpoint for chemoimmunotherapy with rituximab/bendamustine among patients clinical outcomes in patients receiving radiotherapy plus long-term aged $ 65 years with untreated chronic lymphocytic (CLL). No androgen deprivation for locally advanced prostate cancer. difference was observed between ibrutinib alone and ibrutinib/rituximab. Adjuvant Emtansine vs Trastuzumab in Patients REFERENCES With HER2-Positive Breast Cancer With Residual Disease 1. US Food and Drug Administration: Home page. http://www.fda.gov 2. US Food and Drug Administration: Home page. http://www.fda.gov After Neoadjuvant Therapy 3. Woyach JA, Ruppert AS, Heerema NA, et al: Ibrutinib regimens versus chemo- As reported at the recent San Antonio Breast Cancer Symposium and in immunotherapy in older patients with untreated CLL. N Engl J Med 379:2517-2528, 2018 The New England Journal of Medicine by von Minckwitz et al,4 an interim 4. von Minckwitz G, Huang C-S, Mano MS, et al: for residual invasive HER2-positive breast cancer. N Engl J Med DOI: 10.1056/NEJMoa1814017 analysis of the phase III KATHERINE trial has shown that adjuvant 5. Conroy T, Hammel P, Hebbar M, et al: FOLFIRINOX or gemcitabine as adjuvant therapy for trastuzumab emtansine improved invasive disease–free survival vs pancreatic cancer. N Engl J Med 379:2395-2406, 2018 trastuzumab in patients with HER2-positive breast cancer with residual 6. Holmqvist AS, Chen Y, Berano J, et al: Risk of solid subsequent malignant neoplasms disease after neoadjuvant therapy. after childhood Hodgkin lymphoma-identification of high-risk populations to guide sur- veillance: A report from the Late Effects Study Group. Cancer https://doi.org/10.1002/ Adjuvant FOLFIRINOX Versus Gemcitabine in cncr.31807 7. Jackson GH, Davies FE, Pawlyn C, et al: Lenalidomide maintenance versus observation for Pancreatic Cancer patients with newly diagnosed multiple myeloma (Myeloma XI): A multicentre, open-label, In a phase III trial reported in The New England Journal of Medicine, randomised, phase 3 trial. Lancet Oncol 20:P57-73, 2019 5 fi fl 8. Dignam JJ, Hamstra DA, Lepor H, et al: Time interval to biochemical failure as a surrogate Conroy et al found that adjuvant modi ed FOLFIRINOX ( uorouracil, end point in locally advanced prostate cancer: Analysis of randomized trial NRG/RTOG leucovorin, irinotecan, oxaliplatin) produced better disease-free and 9202. J Clin Oncol 37:213-221, 2019