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.
Tisagenlecleucel Approaches EU Approval for Relapsed/Refractory Follicular Lymphoma
March 25th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of tisagenlecleucel for use in adult patients with relapsed/refractory follicular lymphoma following 2 lines of systemic treatment.
NDA Resubmitted to FDA for Pedmark in Prevention of Platinum-Induced Ototoxicity in Solid Tumors
March 24th 2022A new drug application for a unique formulation of sodium thiosulfate was resubmitted to the FDA for the second time for the prevention of platinum-induced ototoxicity in patients between the ages of 1 month and 18 years who have localized, nonmetastatic, solid tumors.
Concurrent Durvalumab/Chemoradiation Misses PFS End Point in Locally Advanced Cervical Cancer
March 24th 2022Durvalumab given concurrently with chemoradiation was not found to significantly improve progression-free survival vs chemoradiation alone in patients with locally advanced cervical cancer, missing the primary end point of the phase 3 CALLA trial.
FDA Issues Complete Response Letter to Sintilimab/Chemo for Frontline Nonsquamous NSCLC
March 24th 2022The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.
New Class of Oncogenic Fusions Revealed in Lung and Pancreatic Cancer
March 24th 2022A Yale Cancer Center research team has identified novel oncogenic gene fusions in lung and pancreatic cancer, as well as sarcoma. The fusions involve RASGRF1 (an activator of RAS signaling) and promote cellular changes leading to tumor development.
Relatlimab/Nivolumab Combo Represents ‘Paradigm-Changing’ Advance in Metastatic Melanoma
March 24th 2022Hussein A. Tawbi, MD, PhD, discusses the recent FDA approval of relatlimab/nivolumab in metastatic melanoma, the significance of the regulatory decision, and potential avenues for further exploration of the regimen.
FDA Approves Pluvicto for Progressive, PSMA-Positive Metastatic CRPC
March 23rd 2022The FDA has approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have previously received other anticancer therapies.
Temozolomide Followed by Low-Dose Ipilimumab/Nivolumab Shows Potential in MSS and MGMT-Silenced mCRC
March 23rd 2022Temozolomide priming followed by the combination of low-dose ipilimumab and nivolumab may produce durable clinical benefit in microsatellite stable and MGMT-silenced metastatic colorectal cancer.
Cilta-cel Offers Durable Option for Heavily Pretreated Multiple Myeloma
March 23rd 2022The FDA has approved ciltacabtagene autoleucel for the treatment of adult patients with relapsed/refractory multiple myeloma, following 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Axi-Cel Shows Clinically Meaningful Improvement in QOL in Second-Line Relapsed/Refractory LBCL
March 23rd 2022Axicabtagene ciloleucel demonstrated a clinically improvement in quality of life compared with standard of care chemotherapy in the second-line setting for patients with relapsed/refractory large B-cell lymphoma.
Third Dose of COVID-19 Vaccine Improves Response in Patients Treated with HCT and Cellular Therapies
March 22nd 2022Muhammad Bilal Abid, MD, MRCP, discusses clinical takeaways regarding the standard use of a third SARS-CoV-2 mRNA vaccine dose among patients treated with hematopoietic cell transplantation, CAR T-cell therapy, and bispecific T-cell engagers.
Abemaciclib/Letrozole Combo Shows Promise in Recurrent ER+ Endometrial Cancer
March 22nd 2022The combination of abemaciclib and letrozole produced encouraging responses with an acceptable toxicity profile in patients with estrogen receptor–positive, recurrent or metastatic endometrial cancer with endometrioid histology, according to data from a phase 2 trial.
Updated KEYNOTE-564 Data Continue to Underscore Benefit of Adjuvant Pembrolizumab in RCC
March 22nd 2022Toni K. Choueiri, MD, discusses follow-up data from the pivotal phase 3 KEYNOTE-564 examining adjuvant pembrolizumab in patients with clear cell RCC and additional areas that are ripe for further research.
Nab-Paclitaxel Plus Pembrolizumab Produces Promising Responses in Advanced Urothelial Cancer
March 22nd 2022Nab-paclitaxel plus pembrolizumab produced an encouraging overall response rate with manageable safety in patients with advanced urothelial cancer who were refractory to platinum-based chemotherapy or cisplatin ineligible, according to data from the phase 2 ABLE trial.
FDA Approves Pembrolizumab for Select MSI-H/dMMR Advanced Endometrial Cancer
March 21st 2022The FDA has approved pembrolizumab for use as a single agent in the treatment of patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, and who experienced disease progression following previous systemic therapy in any setting and are not candidates for curative surgery or radiation.
Regorafenib/Pembrolizumab Misses PFS End Point in MSS CRC, But Biomarker Analyses Are Ongoing
March 21st 2022Afsaneh Barzi, MD, PhD, discusses the safety and efficacy of regorafenib in combination with pembrolizumab in patients with MSS colorectal cancer and describes potential next steps for further exploration of novel combinations in this population.
Breast Cancer Treatment Advances Lead to Broadened Scope of Personalized Medicine
March 21st 2022Harold J. Burstein, MD, PhD, discusses treatment updates across HER2-positive breast cancer, adjuvant advances in estrogen receptor–positive disease, and the domino effect of immunotherapy in triple-negative breast cancer.