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FDA Grants Fast Track Designation to Eltanexor for R/R Myelodysplastic Syndrome
July 21st 2022Following positive phase 1 study results for eltanexor monotherapy in patients with relapsed or refractory intermediate, high-, or very high-risk myelodysplastic syndrome, the FDA has granted the drug fast track status.
Ofra-vec/Paclitaxel Shows No Significant Survival Benefit in Platinum-Resistant Ovarian Cancer
July 20th 2022The phase 3 OVAL clinical trial has been discontinued after the combination of ofranergene obadenovec and paclitaxel did not achieve the study’s primary end points of improvement in progression-free and overall survival.
KEYNOTE-412 Fails to Show EFS Advantage in Unresected Locally Advanced HNSCC
July 20th 2022Patients with unresected locally advanced head and neck squamous cell carcinoma did not show a significant improvement in event-free survival when treated with pembrolizumab and concurrent chemoradiation followed by pembrolizumab maintenance in the phase 3 KEYNOTE-412 study.
FDA Grants Fast Track and Rare Pediatric Disease Designations for WU-CART-007 in T-ALL/LBL
July 20th 2022The FDA has granted fast track designation and rare pediatric disease designation for WU-CART-007 as treatment for patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma.
Higher Residual Cancer Burden Score Linked to Worse Event-Free Survival in TNBC
July 18th 2022In an interview with Targeted Oncology, Lajos Pusztai, MD, DPhil, discussed the updated findings of the phase 3 KEYNOTE-522 clinical trial of pembrolizumab plus chemotherapy in patients with TNBC vs placebo plus chemotherapy.
Air Pollution and Cancer Risk Found Among Black, Low-Income Residents in Louisiana
July 18th 2022Investigators at Tulane University have identified a relationship that linked cancer incidence and cancer risk from air pollution in Louisiana among Black or low-income communities, which were more likely to be affected than other populations.
FDA’s ODAC Discusses Framework for Decision-Making in Pediatric Assessments
July 18th 2022The Pediatric Oncology Subcommittee of the FDA’s Oncologic Drug Advisory Committee met to discuss the assessment of new drugs for the treatment of pediatric cancers. The goal of the meeting was to develop a new framework for application review.
Pertuzumab-Based Regimen Shows Continued Benefit in HER2-Positive Breast Cancer
July 15th 2022Findings from the phase 3 APHINITY study show that the combination pertuzumab, trastuzumab, and chemotherapy improves invasive disease-free survival compared with trastuzumab and chemotherapy alone in patients with lymph node-positive, HER2-positive early breast cancer.
ctDNA Informs Adjuvant Chemotherapy Decision in Patients With Stage II Colon Cancer
July 15th 2022In an interview with Targeted Oncology, Cristian Tomasetti, PhD, discussed the role of circulating tumor DNA in understanding the need for adjuvant chemotherapy in patients with stage II colon cancer. He explained how circulating tumor DNA can signal a patient’s risk of disease recurrence after surgery.
Experts Anticipate New Results From Sotorasib for KRAS G12C+ NSCLC
July 14th 2022A highly anticipated presentation at the 2022 World Conference on Lung Cancer will be the first report of efficacy and safety from the phase 1b/2 CodeBreak 101 clinical trial and will provide updated results from the phase 2 CodeBreak 100 study.
Takeaways From CheckMate-649 in Gastric/GEJ/Esophageal Cancers
July 14th 2022Ryan Sugarman, MD, discusses the key takeaways from the CheckMate-649 trial of patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma receiving nivolumab combined with chemotherapy compared with chemotherapy alone in the first-line.