All Oncology News

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.

EMA Accepts Marketing Authorization Application for Aumolertinib in EGFR-Mutated NSCLC

December 2nd 2022

Pharmaceutical manufacturer EQRx announced December 2, 2022, that the European Medicines Agency has accepted a marketing authorization application for the use of aumolertinib in EGFR-mutated non–small cell lung cancer and locally advanced or metastatic EGFR T790M mutation–positive NSCLC.

FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma

December 2nd 2022

The FDA has granted an orphan drug designation to AUM302 for the treatment of patients with neuroblastoma.

PI3K Inhibitors Face Challenges in Hematologic Malignancies

December 2nd 2022

The PI3K cell-signaling network has been an important therapeutic target in oncology research for nearly 40 years ago, but the use of PI3K inhibitors in hematologic malignancies has come under scrutiny amid concerns about efficacy and safety.

Novel Antibody-Drug Conjugates May Provide Effective and Targeted Treatment for NSCLC

December 2nd 2022

Stephen V. Liu, MD, highlights the advantages of antibody-drug conjugates in lung cancer treatment, the current landscape of antibody-drug conjugate development, and several questions and considerations for continued investigation.

FDA Approves Olutasidenib for IDH1-Mutated Relapsed/Refractory AML

December 1st 2022

The FDA has approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test.

Zimberelimab Monotherapy Elicits Responses in PD-L1–Positive Recurrent or Metastatic Cervical Cancer

December 1st 2022

Zimberelimab monotherapy demonstrated durable responses and was well tolerated in patients with PD-L1–positive, recurrent or metastatic cervical cancer who had progressed after first- or subsequent-line, platinum-containing chemotherapy, according to data from a phase 2 trial.

Helsinn Birex Pharmaceuticals Withdraws European MAA for Infigratinib for Advanced Cholangiocarcinoma

December 1st 2022

The European marketing authorization application of infigratinib for the treatment of advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements has been withdrawn by Helsinn Birex Pharmaceuticals.

FDA Grants Fast Track Designation to Pelareorep for Advanced/Metastatic Pancreatic Cancer

December 1st 2022

The FDA has granted a fast track designation to pelareorep for use in combination with atezolizumab, gemcitabine, and nab-paclitaxel for the treatment of patients with advanced or metastatic pancreatic cancer.

FDA Accepts BLA of Denileukin Diftitox Reformulation for Persistent or Recurrent Cutaneous T-cell Lymphoma

December 1st 2022

The FDA has accepted a biologics license application seeking the approval of a reformulation of denileukin diftitox for use as a potential therapeutic option in patients with persistent or recurrent cutaneous T-cell lymphoma.

Study Shows That Immune System Holds Clues To Patients With High-risk Smoldering Myeloma Likely To Benefit From Treatment

December 1st 2022

In a new study, investigators at Dana-Farber Cancer Institute demonstrate that changes in immune system cells can indicate which patients with high-risk "smoldering" myeloma are likely to progress to myeloma and which will benefit the most from treatment.

Trastuzumab Deruxtecan Demonstrates Promising Clinical Activity in Heavily Pretreated HER2-Low Gastric/GEJ Adenocarcinoma

December 1st 2022

Fam-trastuzumab deruxtecan-nxki induced tumor reduction in more than 60% of patients with HER2-low gastric or gastroesophageal junction adenocarcinoma.

BRONx-CAN Program Aims to Deliver the Best Cancer Treatments Early

December 1st 2022

Montefiore Einstein Cancer Center hopes to begin combating systemic inequities and improve cancer outcomes for historically disadvantaged populations by taking a data-driven approach to delivering neoadjuvant therapy in communities that are economically and socially marginalized.

NEOpredict-Lung Data Support the Addition of Relatlimab to Preoperative Nivolumab in Resectable NSCLC

December 1st 2022

Evan J. Lipson, MD, expands on key takeaways from the NEOpredict-Lung trial, the additional benefit that PICIT may offer to patients who progress on other immunotherapies, and the effect that both NEOpredict-Lung and RELATIVITY-047 have on the role of immunotherapy in the lung and melanoma treatment paradigms.

Enzalutamide Plus Salvage Radiation Therapy Delays PSA Progression in PSA-Recurrent High-Risk Prostate Cancer

November 30th 2022

Six months of enzalutamide monotherapy in combination with salvage radiation therapy postponed prostate-specific antigen progression compared with SRT alone in men with PSA-recurrent, high-risk prostate cancer.

CG0070/Pembrolizumab Combo Shows Promising Efficacy and Tolerability in NMIBC

November 30th 2022

The oncolytic vaccine CG0070 plus pembrolizumab demonstrated encouraging response rates and a tolerable safety profile in patients with non–muscle invasive bladder cancer unresponsive to Bacillus Calmette-Guérin.

Berzosertib Plus Standard Chemoradiation Elicits Promising Responses in Locally Advanced HNSCC

November 30th 2022

Aarti Bhatia, MD, discusses the rationale for investigating berzosertib in this patient population, key updates from the phase 1 trial, and how these findings support the need for continued research of novel regimens in HNSCC.

Nivolumab-Based Therapy Drives Durable Responses in Recurrent/Metastatic Cervical Cancer

November 30th 2022

Nivolumab alone or in combination with ipilimumab produced encouraging responses that were maintained over time in patients with recurrent or metastatic cervical cancer.

Sylvester Researchers Focus on Understanding Role of H. pylori in Gastric Cancer

November 30th 2022

Helicobacter pylori infection is a major cause of gastric cancer, and researchers at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine have several projects underway to better understand the association and develop much-needed prevention and treatment.

FDA Grants Fast Track Designation to Batiraxcept for Advanced or Metastatic Clear Cell RCC

November 30th 2022

The FDA has granted a fast track designation to batiraxcept for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1 or 2 prior lines of systemic therapy that include both immuno-oncology–based and VEGF TKI–based therapies, either in combination or sequentially.

Tremelimumab Plus Durvalumab Receives Go-ahead for Treatment of HCC

November 30th 2022

Ghassan K. Abou-Alfa, MD, discusses the administration of tremelimumab plus durvalumab in hepatocellular carcinoma and where the combination will fit in the treatment paradigm.