News

The FDA granted Priority Review to the New Drug Application for trilaciclib for the treatment of patients with small cell lung cancer who are receiving chemotherapy.

Pazopanib was confirmed active with manageable toxicities as treatment of patients with progressive radioactive-iodine–refractory differentiated thyroid cancer, based on results of a prospective study.

David Roberge, MD, discusses the current role of radiosurgery in the brain metastasis treatment paradigm, a topic he reviewed during a presentation at the 2020 Society of Neuro-Oncology Conference on Brain Metastases.

The Oncologic Drugs Advisory Committee of the FDA voted 9 to 1 in favor of the approval of remestemcel-L, an allogeneic cell therapy, for the treatment of children with steroid-refractory acute graft-versus-host disease.

The FDA has accepted a New Drug Application for umbralisib as treatment of patients with previously treated marginal zone lymphoma who have received at least 1 prior regimen with anti-CD20 therapy and for patients with follicular lymphoma who have received at least 2 prior systemic therapies.

Prostate-specific antigen changes were observed 6 weeks after the administration of 177Lu-PSMA in men with metastatic castration-resistant prostate cancer, suggesting a prognostic value for long-term clinical benefit, according to a single center retrospective analysis.

Leronlimab, demonstrated improvement in total clinical symptom score at day 3 in patients with mild-to-moderate symptoms from coronavirus disease 2019.

Combining temsirolimus with a chemotherapy regimen as treatment of patients with relapsed or refractory mantle cell lymphoma is feasible, according to the phase 1b T3 clinical trial.

A phase 2 clinical trial of radioactive iodine–refractory differentiated thyroid cancer demonstrated that the lenvatinib starting dose of 24 mg is superior to the lower dose of 18 mg, missing the noninferiority primary end point of the study.

The FDA has granted a fast track designation to a novel antibody-drug conjugate for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to 3 prior lines of systemic therapy, or for patients who previously received 4 lines of systemic therapy regardless of their platinum status.

Adjuvant nivolumab prolonged disease-free survival as treatment of patients with resected esophageal or gastroesophageal junction cancer compared with placebo, meeting the primary end point of the phase 3 CheckMate-577 clinical trial.

Overall survival and progression-free survival were improved with nivolumab plus ipilimumab and chemotherapy compared with chemotherapy alone as frontline treatment of patients with metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

Sintilimab in combination with platinum and pemetrexed chemotherapy as frontline treatment of patients with locally advanced or metastatic nonsquamous non–small cell lung cancer improved survival and responses with durable responses observed, according to findings from the ORIENT-11 trial.

The FDA issued a complete response letter to Fennec Pharmaceuticals Inc, developer of a sodium thiosulfate formulation, Pedmark, which is intended for the treatment of patients aged 18 years or younger with localized, non-metastatic solid tumors, as prevention of cisplatin-induced ototoxicity.

In an interview with Targeted Oncology, Salles, explained the unmet needs in DLBCL that may be filled by this new option in the treatment armamentarium and the findings that led to the approval of the combination.

Sequential afatinib followed by osimertinib led to a median overall survival of 47.6 months in patients with EGFR T790M–positive non–small cell lung cancer, according to results from the real-world study, GioTag.

Nivolumab in combination with ipilimumab significantly improved overall survival (OS) in treatment-naïve patients with unresectable malignant pleural mesothelioma (MPM) who were treated in the phase 3 CheckMate 743 clinical trial.

The FDA has approved the Guardant360 CDx liquid biopsy for tumor mutation profiling in patients with any solid malignant neoplasm. This represents the first liquid biopsy companion that is FDA-approved for comprehensive tumor mutation profiling across all solid tumors.

In an interview with Targeted Oncology, Grzegorz S. Nowakowski, MD, discussed the promise of the enzastaurin in the diffuse large B-cell lymphoma treatment landscape and the ongoing phase 3 ENGINE study.

Four cycles of R-CHOP alone should be the new standard approach to limited-stage disease for the majority of patients with diffuse large B-cell lymphoma. That’s the conclusion of a new study that used positron emission tomography–directed treatment approaches to assess the outcomes and toxicity associated with the current standard of care.

A new study has identified genomic factors that appear to correlate with a better risk profile and better progression-free survival among patients with multiple myeloma. The findings, though preliminary, could someday lead to better patient empowerment and stratification.

The combination of CS1001 and chemotherapy led to an improvement in progression-free survival among patients with stage IV squamous and non-squamous non–small cell lung cancer, according to data from the phase 3 CS1001-302 clinical trial assessed by an Independent Data Monitoring Committee, achieving the study’s primary end point.

Frontline treatment with the immune checkpoint inhibitor pembrolizumab as monotherapy generated promising activity against cutaneous squamous cell carcinoma with durable responses and a manageable safety profile.

Targeted Oncology reviews trending news online for the week of August 7, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

A completed Biologics License Application was submitted to the FDA for omburtamab, an investigation monoclonal antibody, which is intended for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

The triplet combination of obinutuzumab plus ibrutinib with venetoclax demonstrated encouraging response rates in patients with treatment-naïve chronic lymphocytic leukemia.

"These data are significant, as they demonstrate that CAR T-cell therapy may be a safe and effective treatment option for patients with Hodgkin lymphoma and potentially other lymphomas expressing the CD30 antigen."

Physicians are at the early stages of realizing the varying mechanisms of resistance to EGFR tyrosine kinase inhibitors and the methods for managing and/or overcoming resistance.

The FDA granted approval to belantamab mafodotin-blmf for the treatment of patients with relapsed or refractory multiple myeloma who previously received treatment with at least 4 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

In an interview with Targeted Oncology, Hearn Jay Cho, MD, PhD, and Irene M. Ghobrial, MD, both discussed the importance of the CureCloud study for the multiple myeloma community, and their hopes for what this study can achieve for myeloma patients and their physicians.