Nivolumab/Chemo Granted Priority Review for Frontline Metastatic Gastric, GEJ, and Esophageal Cancer
January 20th 2021The FDA has granted a priority review to a supplemental biologics license application for nivolumab (Opdivo) in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma.
Padeliporfin ImPACT Granted Fast Track Status for Upper-Tract Urothelial Cancer
January 19th 2021The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.
Immunotherapy Is Promising, Yet Understudied in Myeloid Malignancies
January 18th 2021Survival for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) remains poor, and although immunotherapy has been positioned as a holy grail, it would be preemptive to predict its future based on the number of small studies that have been performed to date, according to Amer Zeidan, MD, MHS.
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for HER2+ Gastric Adenocarcinomas
January 16th 2021The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with locally advanced or metastatic HER2-postive gastric or gastroesophageal (GEJ) adenocarcinoma who previously received a trastuzumab-based regimen.
FDA Approves Crizotinib for Pediatric/Young Adult ALK+ Anaplastic Large Cell Lymphoma
January 15th 2021The FDA has approved crizotinib for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma.
Team Up, Be Aggressive: Improving Outcomes for Metastatic Colon Cancer
January 14th 2021The management of patients with colorectal liver metastases is complicated and requires careful assessment from a multidisciplinary tumor board—especially in light of recent advances made with chemotherapy, according to Michael J. Cavnar, MD.
Eganelisib/Nivolumab Is Encouraging for Metastatic Urothelial Cancer
January 13th 2021The addition of eganelisib (IPI-549) to nivolumab (Opdivo) was found to elicit encouraging responses and improve progression-free survival (PFS) compared with single-agent nivolumab in patients with platinum-refractory, immunotherapy-naïve, advanced, metastatic urothelial cancer, according to an update from the phase 2 MARIO-275 (NCT03980041).
Cavrotolimod Granted Fast Track Status for Merkel Cell Carcinoma, CSCC
January 12th 2021The FDA has granted fast track designations to cavrotolimod (AST-008) for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma (MCC) that is refractory to previous PD-1 blockade and for use in combination with a PD-1/PD-L1 agent in those with advanced or metastatic cutaneous squamous cell carcinoma (CSCC) that is refractory to previous PD-1/PD-L1 blockade.
FDA Updates Darolutamide Label for Prostate Cancer
January 11th 2021The FDA has approved a supplemental new drug application to add overall survival (OS) and other secondary end point data from the phase 3 ARAMIS trial (NCT02200614) to the prescribing information for darolutamide (Nubeqa) for the treatment of patients with nonmetastatic prostate cancer (nmCRPC).
More Targets Discovered, More Molecular Testing Needed in Lung Cancer
January 9th 2021Molecular testing is a critical component of the treatment selection process in lung cancer, as a host of effective drugs have since been developed to target alterations such as ALK, ROS1, and RET, according to Yujie Zhao, MD, PhD, who added that the integration of RNA-based sequencing into these strategies could potentially provide further benefit to patients.
Genetic Precursors to Pediatric Rhabdomyosarcoma Identified
January 7th 2021“But our study is pointing to new genes to consider. For example, we found that the BRCA2 gene, typically associated with adult breast and ovarian cancer, may also somehow influence the susceptibility of pediatric RMS.”
Personalized Approach May Boost AI Adherence
January 6th 2021Twice-weekly text message reminders did not improve adherence to aromatase inhibitors (AIs) for postmenopausal patients with early-stage breast cancer; therefore, increasing the odds of long-term adherence for this population will require more personalized approaches, explained Julie Gralow, MD.
ADC ARX788 Gets Fast Track Status for HER2+ Metastatic Breast Cancer
January 6th 2021The FDA has granted a fast track designation to the investigational antibody-drug conjugate (ADC) ARX788 for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer who have previously received 1 or more HER2-targeted regimens in the metastatic setting.
HER2-Positive Breast Cancer Biomarkers: The Search Continues
January 5th 2021Patients with early-stage HER2-positive breast cancer should be treated with neoadjuvant therapy rather than surgery to determine how they will respond to ado-trastuzumab emtansine (T-DM1; Kadcyla)in the adjuvant setting, according to Ian E. Krop, MD, PhD, who added that although residual disease may serve as a potential predictive biomarker for response to this approach, the hunt for effective molecular biomarkers continues.