Experts Identify Steps to Improve Representation of African Americans in Multiple Myeloma Studies
March 4th 2021“The importance of diverse representation cannot be underscored enough and is critical to ensure that safe and effective products are available to the [United States] patient population,” wrote the study authors, who were led by Nicole Gormley, MD.
Lower Radiotherapy Dose Shows Promise for Treating HPV-Related Oropharyngeal Cancer
March 3rd 2021Given the current study findings, investigators suggested intratherapy personalization of chemoradiotherapy may possibly facilitate marked de-escalation of radiotherapy in patients with HPV-related oropharyngeal cancers.
Adding Adavosertib to Gemcitabine Extends PFS and OS in Advanced High-Grade Serous Ovarian Cancer
March 3rd 2021In a phase 2 study, adavosertib plus gemcitabine showed signs of activity in platinum-resistant or platinum-refractory advanced high-grade serous ovarian cancer, including rare histological subtypes of ovarian cancer.
Combination Treatment With Eprenetapopt and Azacitidine Shows Promise for TP53-Mutant MDS and AML
March 2nd 2021“The [phase 1b/2] data [are] promising and support the current phase 3, multicenter trial, which we hope will lead to FDA approval and a new much-needed treatment option for this patient population,” said David Sallman, MD.
Study Identifies Associations Between Low CRC Risk and Prudent Dietary Patterns
March 1st 2021“Emerging evidence supports a possible role for overall dietary patterns that, in totality, emphasize habitually consuming fruits, vegetables, grains, and low-fat dairy and reducing red meat and alcohol intake,” wrote the study authors.
Phase 2 MERECA Trial Continues to Show Promise for Ilixadencel-Sunitinib Combination for mRCC
February 26th 2021“These updated results from the phase 2 MERECA trial underscore the positive impact on overall survival that ilixadencel may achieve for [patients with kidney cancer],” said Sven Rohmann, MD, PhD.
FDA Grants Breakthrough Therapy Designation to Tipifarnib for Treatment of HRAS-Mutant HNSCC
February 24th 2021The breakthrough therapy designation was based on preliminary activity reported in the phase 2 RUN-HN clinical trial, which evaluated tipifarnib in patients with recurrent or metastatic HRAS-mutant head and neck squamous cell carcinoma.
Study Identifies Oncology Health Professionals’ Conflicting Perceptions of Telehealth
February 23rd 2021The results of a study on telehealth give insight into both the potential barriers and possible benefits of these services, which have been widely utilized since the start of the COVID-19 pandemic.
FDA Grants Priority Review to sNDA for Ruxolitinib to Treat Steroid-Refractory cGVHD
February 23rd 2021The sNDA submission for ruxolitinib to treat steroid-refractory chronic graft-versus-host disease in adult and pediatric patients 12 years and older was based on the phase 3 REACH3 study, which is assessing the safety and efficacy of ruxolitinib compared with best available therapy.
FDA Approves Cemiplimab as First-Line Treatment for Advanced, High PD-L1 NSCLC
February 22nd 2021The approval of cemiplimab in non–small cell lung cancer was supported by results from the phase 3 EMPOWER-Lung 1 trial that investigated its use as monotherapy in the first-line setting compared with platinum-doublet chemotherapy in patients with locally advanced or metastatic disease whose tumor cells expressed PD-L1.
Timothy A. Yap, MBBS, PhD, FRCP, on COVID-19 Vaccination for Patients in Phase 1 Cancer Trials
February 19th 2021The medical oncologist and physician scientist based at the University of Texas MD Anderson Cancer Center explained recommendations for SARS-CoV-2 vaccination in patients participating in phase 1 oncology clinical trials.
FDA Grants Priority Review to BLA for Vicineum for Treatment of High-Risk, BCG-Unresponsive NMIBC
February 18th 2021The biologics license application is for the locally administered fusion protein Vicineum for the treatment of high-risk, bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer.
FDA Accepts sNDA for Zanubrutinib for Treatment of Waldenström Macroglobulinemia
February 17th 2021A supplemental new drug application submission was primarily based on safety and efficacy data from the global phase 3 ASPEN trial of zanubrutinib compared with ibrutinib for the treatment of Waldenström macroglobulinemia.
FDA Approves Trilaciclib for Patients With SCLC Being Treated With Chemo
February 12th 2021The approval of trilaciclib was based on results from a pooled analysis of intent-to-treat datasets from 3 studies of patients with extensive-stage small cell lung cancer in which patients received standard chemotherapy plus either trilaciclib or placebo.
FDA Grants Breakthrough Therapy Designation to Asciminib for 2 CML Indications
February 10th 2021The FDA has granted breakthrough therapy designation to asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who have been previously treated with 2 or more tyrosine kinase inhibitors; or who harbor the T315I mutation.
Phase 3 TRYbeCA-1 Trial in Second-Line Pancreatic Cancer Will Continue to Final Analysis
February 9th 2021Per a planned interim superiority analysis conducted by an independent data monitoring committee, a trial of Eryaspace will continue without modification with final results anticipated later this year.