FDA Grants Umbralisib Priority Review for Previously Treated MZL
August 13th 2020The FDA has granted a priority review designation to a new drug application for umbralisib for the treatment of patients with previously treated marginal zone lymphoma who have received at least 1 prior anti-CD20–based treatment.
Read More
Sintilimab/Pemetrexed Regimen Significantly Improves PFS in Advanced NSCLC
August 8th 2020Sintilimab injection plus pemetrexed and platinum-based therapy led to a statistically significant improvement in progression-free survival compared with chemotherapy alone as a first-line treatment for patients with locally advanced or metastatic nonsquamous non–small cell lung cancer.
Read More
FDA Approves Belantamab Mafodotin-blmf for Relapsed/Refractory Multiple Myeloma
August 6th 2020The FDA has approved belantamab mafodotin-blmf (Blenrep) as a treatment for patients with relapsed/refractory multiple myeloma who have received 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
Read More
Entrectinib Approved in Europe for NTRK+ Tumors and ROS1+ NSCLC
August 3rd 2020The European Commission has approved entrectinib for the treatment of adult and pediatric patients ≥12 years of age with solid tumors that harbor an NTRK fusion, as well as for the treatment of adult patients with ROS1-positive, advanced non—small cell lung cancer not previously treated with ROS1 inhibitors.
Read More
FDA Grants Adjuvant Osimertinib Breakthrough Status in Early-Stage EGFR+ NSCLC
July 30th 2020The FDA has granted a breakthrough therapy designation to osimertinib for the adjuvant treatment of patients with stage IB, II, and IIIA EGFR-mutated non–small cell lung cancer following complete resection with curative intent.
Read More
Ruxolitinib Improves ORR in Steroid-Refractory, Dependent Chronic GVHD
July 23rd 2020Ruxolitinib was found to demonstrate a superior objective response rate at 24 weeks compared with best available therapy in patients with steroid-refractory or steroid-dependent chronic graft-versus-host-disease, meeting the primary end point of the phase 3 REACH3 trial.
Read More
Metastatic HER2+ Breast Cancer Treatment Must Move to Personalized Approach
July 17th 2020The optimal sequence of therapies for patients with metastatic HER2-positive breast cancer must be an individualized one, and should be dependent on the presence and/or level of central nervous system disease.
Read More
FDA Panel Supports Belantamab Mafodotin for Relapsed/Refractory Myeloma
July 14th 2020The FDA’s Oncologic Drugs Advisory Committee voted 12 to 0 in favor of approving belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma who have previously received at least 4 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and a CD38-directed antibody.
Read More
Olaparib Approved in Europe for BRCA+ Pancreatic Cancer
July 8th 2020The European Commission has approved single-agent olaparib as a maintenance treatment for adult patients with germline BRCA1/2-mutant metastatic pancreatic adenocarcinoma who have not progressed after a minimum of 16 weeks of a frontline platinum-based chemotherapy regimen.
Read More
Phase 3 Pracinostat Trial Discontinued in Newly Diagnosed AML
July 2nd 2020Patient recruitment has been discontinued to an interim futility analysis of a phase 3 trial evaluating pracinostat in combination with azacitidine in patients with acute myeloid leukemia demonstrated that it is unlikely to meet the primary end point of overall survival compared with a control arm.
Read More
Neoadjuvant Nivolumab/Ipilimumab Improves RFS in Stage III Macroscopic Melanoma
June 24th 2020The neoadjuvant combination of nivolumab and ipilimumab continues to demonstrate a benefit in RFS compared with the combination given in the adjuvant setting in patients with stage III macroscopic melanoma.
Read More
Tiragolumab/Atezolizumab Shows Early First-in-Human Efficacy in Frontline PD-L1+ NSCLC
June 24th 2020Tiragolumab in combination with atezolizumab (Tecentriq) demonstrated early clinical activity and was found to be well tolerated in patients with advanced solid tumors, including those with metastatic non–small cell lung cancer who were PD-L1 positive and had not received prior checkpoint inhibition.
Read More
Pembrolizumab Approved in China for Second-Line PD-L1+ Esophageal Cancer
June 22nd 2020The National Medical Products Administration in China has approved pembrolizumab for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 as determined by an approved test, following disease progression on 1 prior line of systemic therapy.
Read More
iNEST/Atezolizumab Combo Induces Neoantigen-Specific T-Cell Responses in Advanced Solid Tumors
June 22nd 2020The addition of the individualized neoantigen specific immunotherapy RO7198457 to atezolizumab induced neoantigen-specific T-cell responses, and was found to be well tolerated in patients with advanced solid malignancies.
Read More
Ipatasertib/Abiraterone Regimen Improves Radiographic PFS in mCRPC With PTEN Loss
June 19th 2020The combination of ipatasertib plus abiraterone acetate and prednisone/prednisolone improved radiographic progression-free survival compared with standard treatment plus placebo in patients with metastatic castration-resistant prostate cancer who have PTEN loss.
Read More
Neoadjuvant Atezolizumab/Chemo Combo Improves pCR in Early TNBC
June 18th 2020The combination of atezolizumab and nab-paclitaxel, followed by doxorubicin and cyclophosphamide, demonstrated a statistically significant and clinically meaningful improvement in pathological complete response compared with placebo plus chemotherapy as a neoadjuvant treatment for patients with early triple-negative breast cancer, regardless of PD-L1 expression.
Read More
Rolling Submission Completed for Umbralisib in Previously Treated MZL and Follicular Lymphoma
June 17th 2020A new drug application has been completed and submitted to the FDA for the accelerated approval of umbralisib as a treatment for patients with previously treated MZL and follicular lymphoma.
Read More
FDA Grants Liposomal Irinotecan Fast Track Status for Frontline Metastatic Pancreatic Cancer
June 17th 2020The FDA has granted a fast track designation to liposomal irinotecan for use in combination with 5-fluorouracil/leucovorin and oxaliplatin as a treatment for patients with previously untreated, unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma.
Read More
Abemaciclib Significantly Improves iDFS in High-Risk HR+ Early Breast Cancer
June 16th 2020Abemaciclib in combination with standard adjuvant endocrine therapy demonstrated a significant improvement in invasive disease-free survival compared with endocrine therapy alone in patients with high-risk, HR-positive, HER2-negative early breast cancer.
Read More
Plinabulin/Pegfilgrastim Combo Shows Efficacy in Prevention of Severe Neutropenia
June 15th 2020The combination of plinabulin and pegfilgrastim showed a significant enhancement in the rate of grade 4 neutropenia prevention compared with pegfilgrastim alone in patients undergoing chemotherapy, meeting the primary end point of a prespecified interim analysis of the phase 3 PROTECTIVE-2 trial.
Read More
Isatuximab Triplet Significantly Improves PFS in Relapsed/Refractory Myeloma
June 14th 2020The triplet therapy of isatuximab-irfc, carfilzomib, and dexamethasone showed a statistically significant improvement in PFS versus carfilzomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma.
Read More
Ibrutinib/Venetoclax Triplet Demonstrates Frontline Activity in High-Risk CLL
June 12th 2020The triplet regimen of ibrutinib, venetoclax, and obinutuzumab demonstrated encouraging response rates with an acceptable safety profile in treatment-naïve patients with high-risk chronic lymphocytic leukemia.
Read More
Long After COVID-19, Telemedicine Is Here to Stay in Oncology Practice
June 9th 2020Andrew M. Evens, DO, MSc, discusses the telemedicine initiatives that have been taken at RCINJ—even before the COVID-19 outbreak—as well as proper telemedicine etiquette and best practices for oncologists getting a handle on the new approach in clinical practice.
Read More