The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
EU Panel Backs Avelumab/Axitinib Combo for Frontline RCC
September 20th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend approval of the combination of avelumab and axitinib for the frontline treatment of adult patients with advanced renal cell carcinoma.
Risk Patterns Prior to Progression From MGUS to Myeloma Call for Annual Assessments
September 20th 2019Serial assessment of blood-based immune markers showed that the risk of progression from monoclonal gammopathy of undetermined significance, the precursor disease to multiple myeloma is fluctuating rather than determinate, and these patients can experience progression to myeloma within 5 years.
Subset of BRAF non-V600-Mutant mCRC Is Potentially More Sensitive to Anti-EGFR Therapy
September 18th 2019Patients with metastatic colorectal cancer who harbored BRAF non-V600, RAS-dependent mutations were more likely to respond to anti-EGFR therapy versus those with BRAF non-V600, RAS-independent mutations.
ISGIO Presents 16th Annual Gastrointestinal Oncology Conference
September 17th 2019The International Society of Gastrointestinal Oncology, a not-for-profit global educational organization committed to gastrointestinal oncology, will host the 16th Annual Gastrointestinal Oncology Conference from Oct. 10-11, 2019 at the Hilton Crystal City in Arlington, Virginia.
FDA Approves Lenvatinib/Pembrolizumab Combo for Advanced Endometrial Cancer
September 17th 2019The FDA has granted an accelerated approval to the combination of lenvatinib and pembrolizumab for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, and who have disease progression following prior systemic therapy but are ineligible for curative surgery or radiation.
Emerging Biomarkers for Targeted Agents Show Promise in NSCLC
September 17th 2019Alex A. Adjei, MD, PhD, a professor of oncology and pharmacology at Mayo Clinic, discussed the history of five target genes: NTRK, RET, MET, BRAF, and HER2, as well as the exciting data coming out for the lung cancer subset.
Tumor Biology Drives Personalized Surgical Interventions in Breast Cancer
September 17th 2019Shubhada Dhage, MD, FACS, discusses the role of surgery and other therapeutic modalities in breast cancer and explained the shift toward de-escalated treatments and less morbid surgical management strategies.
Lyman Shares Blueprint for Boosting Biosimilar Uptake in Oncology
September 16th 2019Gary H. Lyman, MD, MPH, discusses the current parameters used to develop a biosimilar, the impact these products have had in the treatment and supportive care settings, and ongoing initiatives to address remaining challenges.
FDA Grants Enfortumab Vedotin Priority Review for Urothelial Cancer
September 16th 2019The FDA has granted a priority review designation to a biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.
Ochsner and Statewide Partners Awarded $13.6 Million NCI Grant
September 16th 2019Ochsner Cancer Institute (Ochsner), along with its Gulf South NCI Community Oncology Research Program (NCORP) partners, has been awarded a $13.6 million grant by the National Cancer Institute to expand the successful statewide clinical trials network with a special emphasis on minority and underserved cancer patients.
FDA Issues Warning on Severe Lung Inflammation With CDK4/6 Inhibitors in Breast Cancer
September 13th 2019The FDA is updating the prescribing information and Patient Package Insert for CDK4/6 inhibitors to include a warning that the treatments in rare cases may cause severe inflammation of the lungs.
Fixed-Dose Subcutaneous Pertuzumab Combo Shows Noninferiority in HER2+ Breast Cancer
September 13th 2019A fixed-dose subcutaneous injection of pertuzumab and trastuzumab with hyaluronidase in combination with intravenous chemotherapy demonstrated noninferior pharmacokinetics compared with the standard IV infusions of the regimen in patients with HER2-positive early breast cancer, meeting the primary endpoint of the phase III FeDeriCa trial (NCT03493854).