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.

Vebreltinib Receives Approval in China For MET Exon 14+ NSCLC

November 16th 2023

China’s National Medical Products Administration has granted conditional marketing approval to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET exon 14 skipping mutations.

CCR4 Antagonists May Bolster Immune Responses With Checkpoint Inhibitors in PD-L1+ NSCLC

November 16th 2023

The addition of tivumecirnon to pembrolizumab was safe, well-tolerated, and clinically active vs the historical activity of pembrolizumab monotherapy in patients with checkpoint inhibitor–naive non–small cell lung cancer.

Volrustomig Demonstrates Activity in Treatment-Naive Advanced ccRCC

November 16th 2023

Volrustomig demonstrated efficacy when used as frontline treatment in patients with clear cell renal cell carcinoma with a toxicity profile that is consistent with dual checkpoint inhibition.

FDA Approves Repotrectinib for Locally Advanced or Metastatic ROS1+ NSCLC

November 16th 2023

The FDA has approved repotrectinib (Augtyro) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

New Data From 2023 ESMO Congress Further Define the Evolving Role of ADCs in NSCLC

November 15th 2023

With a plethora of data coming out of the 2023 European Society for Medical Oncology Congress, findings from multiple clinical trials examining antibody-drug conjugates in non–small cell lung cancer demonstrated encouraging antitumor activity and manageable safety profiles, including results from the phase 3 TROPION-Lung01 study, which evaluated datopotamab deruxtecan vs docetaxel in pretreated patients with advanced or metastatic disease.

Regulatory Decisions and Research Boost Management Strategies for Hematologic Malignancies

November 15th 2023

Andrew Kuykendall, MD, discusses the current role of JAK inhibitors in myelofibrosis, the importance of chronic graft-vs-host disease awareness in patients with myeloid malignancies receiving transplant, and unmet needs for patients with chronic myelomonocytic leukemia.

Pembrolizumab Plus Enzalutamide/ADT Fails to Improve rPFS in mHSPC

November 15th 2023

The addition of pembrolizumab (Keytruda) to enzalutamide (Xtandi) and androgen deprivation therapy did not improve radiographic progression-free survival vs placebo plus enzalutamide and ADT in patients with metastatic hormone-sensitive prostate cancer, according to data from the phase 3 KEYNOTE-991 trial presented at the 2023 ESMO Congress.

Diabetes May Accelerate Blood Cancer Growth, Yet Survival Outcomes Differ by Race

November 15th 2023

A first-of-its-kind study unveils how diabetes drives multiple myeloma growth and differences in survival outcomes for Black versus white patients with both conditions

FDA Grants Orphan Drug Designation to SIRPant-M in T-Cell Lymphoma

November 15th 2023

The FDA has granted an orphan drug designation to SIRPant-M™ as a potential therapeutic option for patients with T-cell lymphoma.

Administrative Payment Tasks Could Be Causing Detrimental Effect of Treatment Delays and Nonadherence for Patients With Cancer

November 15th 2023

A possible cause of some of the cost-related delays and nonadherence to treatment that patients with cancer and cancer survivors experience could be the time and effort they are forced to spend on administrative payment tasks related to their care.

FDA Grants Fast Track Designation to RZ-001 for Glioblastoma

November 15th 2023

The FDA has granted fast track designation to the RNA replacement enzyme–based cancer gene therapy RZ-001 for the treatment of patients with glioblastoma, according to an announcement from Rznomics Inc.

Trastuzumab Deruxtecan Demonstrates Real-World Intracranial Efficacy in Metastatic HER2+ Breast Cancer

November 14th 2023

Data from a real-world study in Japan showed that fam-trastuzumab deruxtecan-nxki displayed intracranial efficacy in patients with HER2-positive breast cancer harboring brain metastases and/or leptomeningeal carcinomatosis.

Durvalumab Plus Chemo Wins Approval in China For Advanced/Metastatic Biliary Tract Cancer

November 14th 2023

China’s National Medical Products Administration has approved durvalumab plus gemcitabine and cisplatin for frontline use in adult patients with locally advanced or metastatic biliary tract cancer.

PD-L1 IHC 22C3 pharmDx Gets Green Light From FDA for Determining Pembrolizumab Eligibility in Gastric/GEJ Adenocarcinoma

November 14th 2023

The FDA has approved the PD-L1 IHC 22C3 pharmDx diagnostic tool to aid clinicians in identifying patients with gastric or gastroesophageal junction adenocarcinoma who may be eligible for treatment with the PD-1 inhibitor pembrolizumab.

Adding Immunotherapy to Chemotherapy Regimen Improves Survival in Metastatic Bladder Cancer Patients

November 14th 2023

A clinical trial co-led by Mount Sinai researchers is the first to show that using chemotherapy with immunotherapy resulted in improved survival in patients with an advanced type of bladder cancer.

FG001 Meets Detection End Point in High-Grade Glioma

November 14th 2023

The use of the optical imaging agent FG001 led to the detection of additional cancer by optical guidance in patients with high-grade glioma, meeting the primary end point of the phase 2b FG001-CT-001 trial.

CHMP Supports Approval of Subcutaneous Atezolizumab for All Current IV Indications

November 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer

Momelotinib Approaches EU Approval for Myelofibrosis With Anemia

November 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.

CHMP Recommends Adagrasib for Pretreated KRAS G12C+ Advanced NSCLC

November 14th 2023

After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.

Bayer Withdraws US Indication for Copanlisib in Relapsed Follicular Lymphoma

November 13th 2023

Bayer has announced the intention to voluntarily withdraw the new drug application for copanlisib in adult patients with relapsed follicular lymphoma who have previously received at least 2 prior systemic treatments.