The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
Abivertinib Demonstrates Response and Survival Benefits in Pretreated EGFR T790M–Mutant NSCLC
August 23rd 2022The novel third-generation EGFR inhibitor abivertinib generated a positive overall response rate and overall survival in heavily pretreated Chinese patients with EGFR T790M–mutated non–small cell lung cancer who failed treatment on a first-line EGFR TKI, according to long-term follow-up data from a phase 1/2 trial (NCT02330367).
Maintenance With Niraparib and Ipilimumab Demonstrates PFS Benefit in Pancreatic Cancer
August 23rd 2022Niraparib plus ipilimumab maintenance therapy elicited encouraging progression-free survival results in patients with advanced pancreatic cancer who achieved a stable response to platinum-based chemotherapy.
Tislelizumab/Chemo Combo Takes Step Toward Chinese Approval for Unresectable ESCC
August 23rd 2022The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
Durvalumab Plus Tremelimumab Elicits Favorable PFS Rates in Advanced Sarcomas
August 23rd 2022The combination of durvalumab and tremelimumab demonstrated positive progression-free survival and overall survival rates with expected toxicity data in patients with advanced or metastatic soft tissue and bone sarcomas.
EMA Validates Marketing Authorization Application for Quizartinib in Newly Diagnosed FLT3-ITD+ AML
August 23rd 2022The European Medicines Agency has validated the marketing authorization application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of adult patients with newly diagnosed FLT3-ITD–mutated acute myeloid leukemia.
FDA Grants Breakthrough Therapy Designation to Taletrectinib for ROS1+ NSCLC
August 23rd 2022The FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.
EMA Accepts Marketing Authorization Application for Fixed-Dose Decitabine/Cedazuridine Combo in AML
August 22nd 2022The European Medicines Agency has accepted the marketing authorization application for the oral fixed-dose combination of decitabine and cedazuridine for the frontline treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.
Relma-cel Demonstrates Durable Activity in Relapsed/Refractory LBCL
August 22nd 2022Relmacabtagene autoleucel elicited durable responses and a high overall survival rate in Chinese patients with relapsed/refractory large B-cell lymphoma, according to 2-year follow-up data from the phase 2 RELIANCE trial.
Perioperative Immunotherapy Demonstrates Promising pCR Rates in dMMR/MSI-H Gastric and GEJ Cancer
August 22nd 2022Neoadjuvant nivolumab plus ipilimumab followed by adjuvant nivolumab elicited positive pathologic complete response rates in patients with locally advanced resectable mismatch repair–deficient and/or microsatellite instability–high gastric or gastroesophageal junction adenocarcinoma.
New Breast Center at UI Health Care Aims to Ease the Cancer Journey for Patients
August 22nd 2022The new breast center at UI Holden Comprehensive Cancer Center aims to make the cancer journey easier and less stressful for patients by providing access to the state's most advanced cancer services in 1 convenient location.
Bevacizumab Biosimilar CT-P16 Approved in Europe for Multiple Cancer Types
August 19th 2022The European Commission has approved the bevacizumab biosimilar, CT-P16, for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.
FDA Grants Orphan Drug Designation to Fixed-Dose Senaparib/Temozolomide Combo for SCLC
August 19th 2022The FDA has granted an orphan drug designation to the fixed-dose combination capsule of the PARP inhibitor senaparib and temozolomide for the treatment of adult patients with small cell lung cancer.
Sylvester Researcher Leads Novel Pancreatic Cancer Study, Paving Way for Prestigious PanCAN Grant
August 19th 2022Jashodeep Datta, MD, associate member of Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, led a study recently published in the journal Oncogene that helps to explain pancreatic cancer’s notorious virulence and resistance to therapy.
Dual Checkpoint Blockade Holds Promise as Long-term Treatment Option in NSCLC
August 19th 2022Stephen V. Liu, MD and Neal E. Ready, MD, PhD, discuss the new data with nivolumab plus ipilimumab in treatment-naïve NSCLC and provide commentary on treatment considerations for patients who are eligible to receive these regimens.
CART-ddBCMA Generates Deep Responses in Relapsed/Refractory Multiple Myeloma
August 19th 2022Matthew J. Frigault, MD, discusses the findings from a phase 1 trial investigating the safety and efficacy of CART-ddBCMA in patients with multiple myeloma in whom all previous lines of treatment had failed and shares additional research opportunities for the CAR T-cell therapy.
European Commission Approves Melphalan Flufenamide for Relapsed/Refractory Multiple Myeloma
August 18th 2022The European Commission has approved melphalan flufenamide for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 3 prior therapies.
CCNE1 Amplifications Tied to Racial Disparities in Serous Endometrial Cancer Outcomes
August 18th 2022Julian Schink, MD, discusses a study evaluating racial differences in the mutational landscape of serous endometrial cancer, underscores the need for appropriate genomic testing and treatment for Black women with the disease, and explains the importance of racial representation across clinical trials.