FDA Approves Frontline Nivolumab/Ipilimumab/Chemo for Advanced NSCLC
May 26, 2020 09:30pm
By Lisa Astor
Targeted Oncology reviews trending news online for the week of May 22, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.
In the last week, there have been a number of updates from the FDA, including the approval of an immunotherapy combination for the treatment of a non–small cell lung cancer (NSCLC) subgroup. A Breakthrough Therapy designation was also granted for a new treatment option for patients with HER2-mutated metastatic NSCLC.
Other major FDA news from the past week included the approval of the PARP inhibitor olaparib (Lynparza) in metastatic castration-resistant prostate cancer, as well as the approval of rucaparib (Rubraca) in this patient population; the fifth approved indication for atezolizumab in NSCLC; an approval in the Kaposi sarcoma treatment landscape; and an approval for the treatment of advanced gastrointestinal stromal tumors.
The combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) has been approved by the FDA for the treatment of metastatic or recurrent NSCLC whose tumors express PD-L1 (≥1%), as determined by an FDA-approved test, and who do not have an EGFR or ALK tumor aberration.
The FDA granted a Breakthrough Therapy designation to fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with HER2-mutant metastatic NSCLC who have progressed on or after treatment with a platinum-based chemotherapy regimen.
According to a new study of close to 600 patients, the JAK1/2 inhibitor ruxolitinib (Jakafi) did not promote or prevent blast phase evolution in patients with myelofibrosis. These findings underscore the importance of screening patients at high risk for allogeneic transplantation eligibility.
In an interview with Targeted Oncology, Robert L. Coleman, MD, FACOG, FACS, of The US Oncology Network, discussed the importance of molecular testing in ovarian cancer and how the treatment landscape will continue to evolve in tailoring treatment to patients based on the biology of their tumors.
Peter Schmid, MD, PhD, of the Barts Cancer Institute, discussed the findings from the interim analysis of the phase III KEYNOTE-522 trial, which is the first study to evaluate immunotherapy in patients with early triple-negative breast cancer.
Vivek Subbiah, MD, of The University of Texas MD Anderson Cancer Center, discusses the potential to combine tivozanib (Fotivda) with other agents, particularly ipilimumab, as treatment of patients with renal cell carcinoma.
Corey S. Cutler, MD, MPH, FRCPC, of the Dana-Farber Cancer Institute, provides insight on the case of a 49-year-old man with chronic graft-versus-host disease and reviews current and emerging treatment options for disease management.
The FDA authorized the initiation of a phase I/II clinical trial investigating the immunotherapy combination rintatolimod (Ampligen) plus interferon alfa-2b as treatment of patients with cancer who are diagnosed with coronavirus disease 2019 (COVID-19). The trial, which is being conducted at the Roswell Park Comprehensive Cancer Center, will determine the safety and effectiveness of the combination as treatment of patients with COVID-19.