
The European Medicines Agency has accepted a marketing authorization application for momelotinib as a treatment for patients with myelofibrosis.

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The European Medicines Agency has accepted a marketing authorization application for momelotinib as a treatment for patients with myelofibrosis.

The FDA has issued a complete response letter to the biologics license application seeking the approval of 131I-omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

It’s long been known that DNA damage caused by environmental triggers, as well as other sources of oxidative stress, contribute to the development and progression of a wide variety of cancers.

Dostarlimab plus standard-of-care chemotherapy, followed by dostarlimab alone, produced a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with primary advanced or recurrent endometrial cancer.

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.

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

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.

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.

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 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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

The combination of NT-I7 and pembrolizumab showed significant clinical activity in checkpoint inhibitor–naïve, relapsed/refractory microsatellite stable colorectal cancer and pancreatic cancer without liver metastasis.

The FDA has granted CB-010 a regenerative medicine advanced therapy designation for relapsed/refractory large B-cell lymphoma and a fast track designation for relapsed/refractory B-cell non-Hodgkin lymphoma.

Mohamad Allaf, MD, discusses innovative and unique aspects of the PROSPER-RCC trial design, areas for continued analysis within the study, and the ways in which this trial will inspire and inform continued research in renal cell carcinoma.

The combination of nivolumab and ipilimumab, irrespective of the addition of stereotactic body radiation therapy, generated an overall response rate of 100% in patients with Merkel cell carcinoma who were naïve to immune checkpoint inhibitors.

Two Fox Chase Cancer Center researchers have received $75,000 grants from the Kidney Cancer Association to pursue studies that could improve kidney cancer treatment and care.

Roche is voluntarily withdrawing the United States indication for atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.