FDA Approves Oral SERD Elacestrant for ESR1-Mutant ER+, HER2– Metastatic Breast Cancer
January 27th 2023The FDA has granted an accelerated approval to elacestrant (Orserdu) for the treatment of patients with estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer following at least 1 prior lines of endocrine therapy.
Tucatinib and Trastuzumab Combination Gains FDA Approval for RAS Wild-Type HER2+ mCRC
January 19th 2023The FDA has granted accelerated approval to tucatinib and trastuzumab for RAS wild-type, HER2-positive metastatic colorectal cancer. The prescribing information includes warnings for diarrhea and hepatotoxicity.
Real-World Patient-Reported Outcomes for Axi-Cel Align With Clinical Trial QOL, Symptomology Data
December 11th 2022Real-world data from patient-reported outcomes suggest that axicabtagene ciloleucel is associated with temporary worsening of quality of life with statistically and clinically significant improvements within 1-year postinfusion.
FDA Schedules ODAC Meetings to Review Pending Drug Applications
August 6th 2022The FDA has scheduled 3 sessions for the Oncologic Drugs Advisory Committee to review updates on the new drug application for poziotinib tablets and data for the continued approval of indications for melphalan flufenamide and duvelisib.
Get to the Root of Cancer Disparities
August 3rd 2020In order to achieve health equity for patients with cancer, physicians must first understand the root cause of heath disparities, many of which may be invisible. Broadening conversations about health and equity, drawing attention to gaps in care, and prompting urgency on the issues that influence health care are crucial first steps to turn conversation into action.
PIK3A-Mutant Breast Cancer Shows Increased Sensitivity to PI3Kα Inhibition
June 27th 2020Patients with breast cancer who harbor multiple PIK3A-mutant tumors achieved a higher clinical benefit from PI3Kα inhibition compared with single mutant tumors according to response analysis data from the SANDPIPER trial.