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.
FDA Issues a Complete Response Letter for Retifanlimab for Squamous Cell Carcinoma of the Anal Canal
July 26th 2021The FDA has issued a complete response letter to Incyte Corporation stating that it cannot approve the biologics license application for retifanlimab for use in adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy, in its present form.
Biosimilars Gain Traction, Generate Savings
July 26th 2021The use of oncology biosimilars has expanded rapidly in the United States during the past 2 years as providers embraced a growing armamentarium of new products, according to findings from real-world data reported at the 2021 American Society of Clinical Oncology Annual Meeting.
Multimodality Approaches Improve Outcomes in Marginally-Inoperable Soft Tissue Sarcoma
July 26th 2021A multimodality approach to treatment, which included sequential chemotherapy and radiation therapy followed by surgery, resulted in successful resection for most patients with marginally inoperable soft tissue sarcomas.
Brentuximab Vedotin Plus Chemo Shows Strong Activity in Early-Stage Hodgkin Lymphoma
July 25th 2021The combination of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine with and without consolidative radiotherapy was found to have strong efficacy and favorable tolerability in patients with early-stage, unfavorable-risk, Hodgkin lymphoma.
Early Changes in ctDNA May Predict Response to CD19-Targeted CAR T-cell Therapy in LBCL
July 23rd 2021Heterogeneity in the cellular and molecular features of CAR T-cell products contributes to variation in efficacy and toxicity follow treatment with axicabtagene ciloleucel in patients with large B-cell lymphoma, and molecular response at day 7 might represent an early predictor of efficacy with this modality.
Emerging Therapies Expand Options in Lung Cancer
July 23rd 2021During the past 12 months, the treatment landscape for patients with non–small cell lung cancer has expanded dramatically with FDA approvals of the first drugs directed at KRAS G12C and EGFR exon 20 mutations as well as continued progress in developing new therapies for subsets of patients with other molecularly targetable alterations and with PD-L1–high disease.
Siddiqi Spotlights Latest Data on Optimization of Therapy in Hematologic Malignancies
July 23rd 2021Data presented during the 2021 ASCO Annual Meeting offered insight into the optimization of BTK inhibitors, induction therapy, consolidative therapy, and radiation therapy for patients across the paradigm of hematologic malignancies.
Emerging Allogeneic CAR T Candidates Usher in a New Era
July 22nd 2021Dose-dependent engraftment of the investigative CAR T-cell therapy CYAD-211 was demonstrated in the first patient with relapsed/refractory multiple myeloma to receive this dose in the phase 1 IMMUNICY-1 trial, and no graft-versus-host disease has been reported to date.
Venetoclax Plus Lenalidomide/Rituximab Elicits High Response Rates in Newly Diagnosed MCL
July 22nd 2021The addition of venetoclax to lenalidomide and rituximab resulted in a high response rate and encouraging minimal residual disease undetectability in patients with newly diagnosed mantle cell lymphoma—even in those with high-risk features.
Transplant-Associated Thrombotic Microangiopathy: New Insights, Emerging Treatments
July 22nd 2021An expert of panelists provide an overview of TA-TMA, including findings that raise suspicion of this complication, strategies they use for making the diagnosis, and how they intervene given limited treatment options.
FDA Grants Regular Approval to Pembrolizumab Plus Lenvatinib for Advanced Endometrial Carcinoma
July 22nd 2021The FDA has granted a regular approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, who have disease progression after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.
MDM2 Inhibitor Milademetan Under Examination in Dedifferentiated Liposarcoma
July 21st 2021The safety and efficacy of the oral MDM2 inhibitor milademetan is under investigation vs trabectedin, a current standard of care, in the treatment of patients with dedifferentiated liposarcoma as part of the recently initiated phase 3 MANTRA trial.