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.
FDA Approval Sought for Poziotinib in HER2 Exon 20–Mutated NSCLC
December 6th 2021A new drug application seeking the approval of poziotinib as a potential therapeutic option for patients with previously treated locally advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations has been submitted to the FDA.
Breast Reconstruction Specialist Dr. Andrea Moreira Joins AHN from Cleveland Clinic
December 6th 2021Andrea Moreira, MD, a board-certified plastic surgeon specializing in the use of advanced techniques in breast reconstruction, has joined Allegheny Health Network from Cleveland Clinic and will serve as Co-Director of the Microsurgery and Breast Reconstruction Program in the AHN Division of Plastic Surgery.
Therapeutic Frontiers Expand for Patients With Relapsed/Refractory Multiple Myeloma
December 6th 2021Various immune strategies have been developed in multiple myeloma, including immune-enhancing drugs such as immunomodulatory drugs, checkpoint inhibitors, monoclonal antibodies, and, more recently, chimeric antigen receptor T-cell therapy and bispecific antibodies for T-cell redirection.
Image-Guided Intensity-Modulated Radiotherapy Shows Reduced Toxicity in Cervical Cancer
December 4th 2021Image-guided intensity-modulated radiotherapy caused less toxicity compared with three-dimensional conformal radiation therapy with no difference in disease outcomes in patients with cervical cancer undergoing postoperative radiation therapy.
FDA Grants Priority Review to Luspatercept-aamt for Non–Transfusion Dependent Beta Thalassemia
December 3rd 2021The FDA has granted priority review to the supplemental biologics license application for luspatercept-aamt for the treatment of anemia in adults with non–transfusion dependent β-thalassemia.
The Evolving Role of Prognostic Markers for CLL in the Era of Novel Agents
December 3rd 2021Deborah M. Stephens, DO, discusses her approach to treating a patients with chronic lymphocytic leukemia, how CAR T-cell therapy may fit into the treatment paradigm, and the numerous trials that have shown promise in this space.
FDA Approves Rituximab/Chemo for Pediatric Cancer Indications
December 3rd 2021The FDA has approved rituximab plus chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
Liso-cel Significantly Prolongs EFS Over SOC in Second-Line Relapsed/Refractory LBCL
December 3rd 2021Lisocabtagene maraleucel significantly prolonged event-free survival and progression-free survival and improved complete responses when used in the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.
Tebentafusp Represents a Potential Frontline Therapy for Patients with Uveal Melanoma
December 2nd 2021Richard D. Carvajal, MD, discusses the need for additional treatment options in patients with rare melanomas, the promise of tebentafusp, and ongoing trials in the pipeline for this patient population.
De-Escalated Approaches Continue to Show Benefit in HER2+ Breast Cancer
December 2nd 2021Deborah L. Toppmeyer, MD, discusses clinical trials involving treatments for HER2-positive and triple-negative breast cancer, as well as the importance of making these trials accessible to all patient populations in an attempt to address disparities.
FDA Grants Breakthrough Device Designation to ZetaMet for Metastatic Bone Cancers
December 1st 2021The FDA’s Centers for Devices and Radiological Health has granted a breakthrough device designation to ZetaMet technology for use in the treatment of metastatic bone cancers and osteologic interventions.
BO-112 Plus Pembrolizumab Improves ORR in Advanced Melanoma After Progression on Anti–PD-1 Therapy
December 1st 2021The addition of BO-112 to pembrolizumab produced clinical benefit in patients with unresectable malignant melanoma who have experienced disease progression on anti–PD-1 therapy, according to data from the preliminary analysis of the phase 2 SPOTLIGHT-203 trial.
FDA Approves Subcutaneous Daratumumab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Myeloma
December 1st 2021The FDA has approved daratumumab and hyaluronidase-fihj plus carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
FDA Issues Complete Response Letter to Plinabulin for Chemo-Induced Neutropenia
December 1st 2021The FDA has issued a complete response letter to the new drug application seeking the approval of plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.