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.
Cemiplimab sBLA in Second-Line Advanced Cervical Cancer Voluntarily Withdrawn
January 29th 2022Regeneron Pharmaceuticals, Inc. and Sanofi announced the voluntarily withdrawal of the supplemental biologics license application for cemiplimab-rwlc as a second-line treatment for patients with advanced cervical cancer whose disease progressed on or after chemotherapy.
Lorlatinib Approved in Europe for ALK+ Advanced NSCLC
January 28th 2022The European Commission has granted a marketing authorization for lorlatinib for use as a single agent in the treatment of adult patients with ALK-positive advanced non–small cell lung cancer who did not receive a prior ALK inhibitor.
2-Year OS Improves Over 20 Years in Relapsed Ph+ ALL Post Allogeneic Transplant
January 27th 2022The 2-year overall survival rate almost doubled between 2000 and 2004 and 2015 and 2019 in patients with Philadelphia chromosome–positive acute lymphoblastic leukemia who had relapsed after allogeneic hematopoietic cell transplant, indicating improvements in patient care overall.
Chemosensitivity Reflects Improved OS Following Adjuvant Chemotherapy in Gastric Cancer
January 26th 2022Neoadjuvant chemosensitivity was associated with an improvement in overall survival following adjuvant chemotherapy in patients with resectable gastric cancer, according to findings from a cohort study that were published in JAMA Network Open.
Incyte Withdraws NDA for Parsaclisib in Relapsed/Refractory Follicular Lymphoma, MZL, MCL
January 26th 2022The global biopharmaceutical company Incyte has decided to withdraw the new drug application for parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.
Nivolumab/Cabozantinib Combo Improves Patient-Reported Outcomes Over Sunitinib in RCC
January 26th 2022The combination of nivolumab and cabozantinib was associated with improved quality of life compared with sunitinib in patients with previously untreated advanced renal cell carcinoma, according to patient-reported outcome data from the phase 3 CheckMate-9ER trial.
American Oncology Network Appoints New Executive Board Member
January 26th 2022The American Oncology Network, LLC, whose mission is to support the long-term viability of community oncology, is pleased to announce that Medical Oncologist Shalin R. Shah, DO has been named to its Executive Board, providing strategic guidance to its growing network of over 100 physicians across 16 states.
Cosibelimab Elicits Encouraging Responses in Metastatic Cutaneous Squamous Cell Carcinoma
January 25th 2022The PD-L1 antibody cosibelimab, when given at a fixed dose of 800 mg every 2 weeks, elicited a promising objective response rate with acceptable safety and tolerability in patients with metastatic cutaneous squamous cell carcinoma, meeting the primary end point of a phase 1 registration-enabling trial.
Long-Term Data Confirm Benefit of Erdafitinib in FGFR-Mutated Urothelial Carcinoma
January 25th 2022The FGFR TKI erdafitinib continued to provide consistent clinical benefits with a manageable safety profile when used in the second-line treatment of patients with locally advanced or metastatic urothelial carcinoma harboring FGFR alterations.