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.
EU Panel Recommends Adjuvant Pembrolizumab for Select RCC Following Surgery
December 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of single-agent pembrolizumab for use as an adjuvant treatment in adult patients with renal cell carcinoma who are at increased risk of recurrence after nephrectomy, or following nephrectomy and the resection of metastatic lesions.
Enfortumab Vedotin Approaches EU Approval for Locally Advanced or Metastatic Urothelial Cancer
December 17th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of enfortumab vedotin as a monotherapy in the treatment of adult patients with locally advanced or metastatic urothelial cancer.
Pembrolizumab Proves Potential as New Standard of Care for RCC in Adjuvant Setting
December 17th 2021Pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in disease-free survival vs placebo as a postnephrectomy adjuvant therapy in patients with renal cell carcinoma at intermediate-high or high risk of recurrence, and in those who are M1 with no evidence of disease.
Real-World Data Underscores Efficacy of Durvalumab in NSCLC
December 17th 2021Real-world data from the PACIFIC-R trial evaluating durvalumab following chemoradiotherapy in patients with stage III, unresectable non–small cell lung cancer provide evidence supporting the agent’s efficacy in this population, solidifying its role as a standard-of-care treatment
Parsaclisib Elicits Encouraging Response Rates in Relapsed/Refractory Follicular Lymphoma
December 17th 2021Parsaclisib, an investigational highly selective phosphatidylinositol 3-kinase δ inhibitor, demonstrated rapid and durable responses as monotherapy with an acceptable safety profile in patients with relapsed/refractory follicular lymphoma in the phase 2 CITADEL-203 study.
Itolizumab May Minimize Incidence of aGVHD Following HSCT, Improve Outcomes
December 16th 2021Itolizumab showed the potential to decrease the response of host T cells to a donor graft, minimize the incidence of acute graft-vs-host disease following hematopoietic stem cell transplantation, and improve outcomes for these patients.
Adavosertib Elicits Efficacy in RAS/TP53+ mCRC With Potential Additive Benefit in Left-Sided Tumors
December 16th 2021The WEE1 inhibitor adavosertib improved progression-free survival with a tolerable safety profile compared with active monitoring in patients with RAS/TP53-mutated metastatic colorectal cancer.
Neoadjuvant Trastuzumab Deruxtecan Dosed in First Patient With Early-Stage HER2+ Breast Cancer
December 16th 2021The first patient with high-risk, early-stage HER2-positive breast cancer has received a dose of neoadjuvant fam-trastuzumab deruxtecan-nxki as part of the global, phase 3 DESTINY-Breast11 trial.
Targeted Drug Combination Shows Unprecedented Activity in Some Highly Aggressive Brain Tumors
December 16th 2021A combination of two targeted cancer drugs showed unprecedented, “clinically meaningful” activity in patients with highly malignant brain tumors that carried a rare genetic mutation, according to a clinical trial report by investigators from Dana-Farber Cancer Institute.
APVO436 Demonstrates Manageable Safety With Anti-Neoplastic Activity in Relapsed/Refractory AML/MDS
December 15th 2021The investigational bispecific antibody APVO436 demonstrated tolerability with encouraging anti-neoplastic efficacy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome, according to updated findings from an ongoing phase 1 trial.
Leading Breast Cancer Surgeon Joins Allegheny Health Network Cancer Institute
December 15th 2021Jill Dietz, MD, FACS, a nationally recognized breast surgeon and leader in the development of innovative, high-quality breast disease treatment centers, has joined Allegheny Health Network Cancer Institute as its Chief Transformation Officer, Director of Breast Growth and Strategy, and clinical breast surgeon.
Cilta-cel Elicits Early, Deep Responses in Heavily Pretreated, Lenalidomide-Refractory Myeloma
December 15th 2021A single infusion of ciltacabtagene autoleucel produced an overall response rate of 95% in patients with multiple myeloma who had received a median of 2 prior lines of treatment and who were refractory to lenalidomide.