News

On the second day of a 2-day meeting of the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drug Advisory Committee, members and guests brought into question the role of real-world data in regulatory decision-making for pediatric oncology drugs.

A retrospective analysis showed there were more durable survival outcomes with avapritinib versus other tyrosine kinase inhibitors in adult patients with gastrointestinal stromal tumors and a platelet-derived growth factor receptor A D842V mutation

After receiving a complete response letter by the FDA, an approval application for ropeginterferon alfa-2b for treatment for patients with polycythemia vera. has been resubmitted to the FDA.

The FDA has granted approval to amivantamab-vmjw for the frontline treatment of adult patients with non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations.

Tislelizumab, an anti-PD-1 antibody combined with gemcitabine and cisplatin demonstrated improvement in progression-free survival (PFS) compared with chemotherapy as first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial, according to a press release by BeiGene, Ltd.

The FDA granted approval to adjuvant nivolumab as treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.

A standing question for oncologists is what to do for patients with tumors smaller than 2 cm. The question led to a debate on whether to administer neoadjuvant chemotherapy to patients with T1c hormone receptor–negative, HER2-positive breast cancer during the 38th Annual Miami Breast Cancer Conference.

In an interview with Targeted Oncology, Sergio A. Giralt, MD, discussed recent data from the study. 

Targeting different pathways may dramatically reduce the risk of resistance emergence and improve outcomes.

PFS Doubles for Advanced Melanoma Patients Treated with Relatlimab Plus Nivolumab.

The FDA has granted a fast track designation to the autologous chimeric antigen receptor T-cell agent, AIC100, for the treatment of patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.

The FDA has accepted a supplemental new drug application for zanubrutinib for the treatment of adult patients with marginal zone lymphoma who have received 1 prior anti-CD20-based therapy. The agent was also granted priority review, with a Prescription Drug User Fee Act target action date of September 19, 2021.

In an interview with Targeted Oncology, Thomas Marron, MD, PhD, discussed neoadjuvant cemiplimab for the treatment of hepatocellular carcinoma.

In an interview with Targeted Oncology, Naseema Gangat, MD, MBBS, discussed her recommendations for managing pregnant patients with myeloproliferative neoplasms.

The FDA has accepted a biologics license application or sintilimab injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non-small cell lung cancer.

The first patient has been dosed in a study designed to evaluate the safety and feasibility of IL13Rα2 chimeric antigen receptor T cell therapy for the treatment of leptomeningeal brain tumors, such as glioblastoma, ependymoma, and medulloblastoma.

The United States Preventive Services Task Force is recommending that individuals at average risk of colorectal cancer begin screening exams at age 45 rather than 50 years of age due to the risk of early on-set colorectal cancer.

Regeneron is resuming enrollment of patients with follicular lymphoma and diffuse large B-cell lymphoma in monotherapy trial of odronextamab after the FDA lifted the partial clinical hold placed on the agent in December 2020.

Brandon Mahal, MD, discusses challenges facing prostate cancer equity.

The LOTIS-2 phase 2 study of loncastuximab tesirine continued to show durable responses and tolerability in relapsed or refractory patients with DLBCL, according to the most recent published results.

Melissa Hardesty, MD, discusses the modern disease management of patients with ovarian cancer in the community setting.

Leonard G. Gomella, MD, discusses deciding between active surveillance and precision medicine in mutated prostate cancer.

In season 2, episode 4 of “Targeted Talks,” Benjamin O. Anderson, MD, FACS, discussed the lessons learned from the COVID-19 pandemic, and preparation for a post-COVID America.

With the emergence of therapies that target PSMA, a cell surface transmembrane protein that is overexpressed in most prostate cancer cells, particularly in castration-resistant disease, the ability to detect and treat the disease has been transformed.

Thomas Marron, PhD, MD, discusses the safety and tolerability of neoadjuvant sunitinib in hepatocellular carcinoma.

Overall survival was prolonged in patients with radioactive iodine-refractory differentiated thyroid cancer and lung metastases larger than 1 cm who were treated with lenvatinib in the SELECT study.

American Oncology Network, LLC announces two key leadership appointments.

In an interview with Targeted Oncology following a webinar, Benjamin O. Anderson, MD, FACS, discussed lessons from COVID-19 in further detail.

Findings suggest that combination regimens may extend overall and progression-free survival.

In an interview with Targeted Oncology, Haris Ali, MD, a hematology oncologist at the City of Hope Cancer Center, discussed the efficacy of ruxolitinib in patients with myelofibrosis, the impact of mutations on ruxolitinib treatment, and the use of the agent in the peri-transplant setting.