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 Grants Orphan Drug Designation to TCB-002 for Relapsed/Refractory AML
March 17th 2022The FDA has granted an orphan drug designation to the investigative allogeneic unmodified gamma delta T-cell product, TCB-002, for use as a potential therapeutic option in patients with relapsed/refractory acute myeloid leukemia.
FDA Grants Fast Track Status to 7HP349 for PD-1–Resistant Metastatic Melanoma
March 17th 2022The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.
Radiotherapy Treatments Are Getting Shorter and Faster in Prostate Cancer
March 17th 2022The history of radiation therapy for men with prostate cancer extends back more than a century. From those early crude methods, the field has advanced to delivery potentially curative therapies that can be administered in as little as 2 weeks.
Uproleselan Plus Chemotherapy Continues to Show Promise in AML
March 17th 2022The addition of uproleselan to standard chemotherapy improved improve response rates and reduced chemotherapy-induced mucositis in patients with newly diagnosed and relapsed/refractory acute myeloid leukemia in a phase 1/2 trial.
Adjuvant Olaparib Significantly Improves OS in BRCA+, High-Risk Early Breast Cancer
March 17th 2022At a median follow-up of 3.5 years, adjuvant olaparib significantly improved overall survival vs placebo in patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who received prior chemotherapy before or after surgery.
Toripalimab/Chemo Combo Provides Significant Survival Benefit in NSCLC Without EGFR/ALK Mutations
March 16th 2022The addition of toripalimab to chemotherapy resulted in improved progression-free survival and overall survival vs chemotherapy alone in patients with treatment-naïve advanced non–small cell lung cancer without EGFR or ALK mutations.
Allarity Therapeutics Requests Type C Meeting With FDA to Discuss Dovitinib in Third-Line RCC
March 15th 2022Allarity Therapeutics, Inc. has filed a formal request with the FDA to hold a Type C meeting where they can discuss possible clinical paths to support the approval of dovitinib in renal cell carcinoma, as well as its DRP-Dovitinib companion diagnostic.
Phase 3 KEYLYNK-010 Trial Examining Pembrolizumab/Olaparib in mCRPC to Stop for Futility
March 15th 2022The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.
Frontline Cabozantinib/Atezolizumab Does Not Improve OS Over Sorafenib in Advanced HCC
March 15th 2022The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.
NCCN Lists Duvelisib in Updated Clinical Practice Guidelines
March 15th 2022The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology has been updated to include duvelisib as a category 2A designated option for second-line and subsequent treatment of patients with relapsed/refractory peripheral T-cell lymphoma.
Neoadjuvant Chemotherapy Benefit Retains Stronghold for Patients With MIBC, UTUC
March 15th 2022Effective treatment paths leveraging neoadjuvant chemotherapy have been well-established for patients with muscle-invasive bladder cancer, with mounting retrospective and prospective data continuing to demonstrate overall survival benefit compared with adjuvant chemotherapy.
Amcenestrant Misses PFS End Point in ER+/HER2– Advanced or Metastatic Breast Cancer
March 14th 2022Amcenestrant did not improve progression-free survival per independent central review vs physician’s choice of endocrine treatment in select patients with locally advanced or metastatic, estrogen receptor–positive, HER2-negative breast cancer, missing the primary end point of the phase 2 AMEERA-3 trial.
FDA Approves Companion Diagnostic for Olaparib in Early Breast Cancer
March 14th 2022The FDA has approved the BRACAnalysis CDx assay for use as a companion diagnostic to select patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who may derive clinical benefit from treatment with olaparib.
Immunotherapy and Targeted Treatment Approaches Improve Outcomes in Metastatic Urothelial Cancer
March 14th 2022Patients with metastatic urothelial carcinoma have multiple effective treatment options approved in both the first line and relapsed settings, with other promising agents and combinations currently in development.
HER2 Expression Drives Treatment Decisions in Gastric/Esophageal Cancers
March 14th 2022Experts in the field of upper gastrointestinal cancers discuss recent data from the European Society for Medical Oncology Congress 2021 that may bolster the uptake of HER2 as a guide for treatment decisions in the second line.
Breast Cancer Management Grows With Innovative, Better Tailored Treatment
March 13th 2022The historical boundaries of what was possible in the management of patients with breast cancer continue to be challenged, evidenced by the use of HER2-directed therapies in patients with brain metastases, de-escalated approaches in patients with visceral disease, and less-invasive surgical techniques for patients with lymph node involvement.