The ongoing coronavirus disease 2019 (COVID-19) pandemic has magnified the value of real-world data (RWD) in oncology. The FDA is presently spearheading several initiatives aimed at refining the role of RWD in cancer care to guide clinical trial development, procure answers to pressing clinical questions, and support regulatory decisions for in vitro diagnostics.
The FDA has had a busy couple of weeks, approving new agents to treat a variety of cancers.
The combination of atezolizumab (Tecentriq) plus carboplatin/etoposide continued to demonstrate an improvement in overall survival (OS) versus chemotherapy alone as a frontline treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), regardless of PD-L1 and blood tumor mutational burden (bTMB) status.
The FDA has approved selinexor as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma, not otherwise specified, who have received ≥2 prior therapies.
Significant differences were seen between Hispanic and non-Hispanic white patients with hematological malignancies in Texas in terms of the age of diagnosis and long-term survival outcomes.
The FDA approved tazemetostat to treat relapsed/refractory follicular lymphoma in 2 different indications.
The FDA has approved pembrolizumab (Keytruda) to treat adult and pediatric patients with unresectable or metastatic solid tumors that are tissue tumor mutational burden–high (≥10 mutations/megabase) and have progressed following prior therapy and who have no satisfactory alternative treatment options.
The FDA expanded the approval of gemtuzumab ozogamicin (Mylotarg) to include newly diagnosed pediatric patients (1 month or older) with CD33-positive acute myeloid leukemia (AML).
The FDA approved lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer with disease progression, following platinum-based chemotherapy.
On Friday, the FDA expanded the approval for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) types 16,18,31, 33, 45, 52, and 58, according to Merck, the manufacturer of the vaccine.
Ruxolitinib (Jakafi) induced a strong, durable response across several subgroups of patients with steroid-refractory acute graft-versus-host disease.
The FDA has approved pegfilgrastim-apgf (Nyvepria), a biosimilar to pegfilgrastim (Neulasta), to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The 4-drug combination of atezolizumab (Tecentriq), bevacizumab (Avastin), carboplatin, and paclitaxel (ABCP) improved survival while maintaining good health-related quality of life (QOL) in patients with nonsquamous non–small cell lung cancer .
Telemedicine will remain a mainstay even after the COVID-19 pandemic, says Andrew M. Evens, DO, MSc.
Brad S. Kahl, MD, discusses the unique challenges that occur when treating patients with indolent non-Hodgkin lymphoma.
Efforts are being made to address remaining questions in the realm of BRAF-mutant melanoma, according to Charles L. Sawyers, MD.
Long-term data presented at the 2020 ASCO Virtual Scientific Program demonstrated that acalabrutinib (Calquence) is safe and effective in patients with treatment-naïve chronic lymphocytic leukemia, supporting its use in the front line setting in this population.
The FDA has granted margetuximab an Orphan Drug designation for the treatment of patients with gastric and gastroesophageal junction (GEJ) cancer, according to MacroGenics, Inc., the manufacturer of the Fc-engineered monoclonal antibody.
Five-year findings from the phase 3 COMBI-AD trial revealed that the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) led to sustained long-term relapse-free survival (RFS) benefit compared with placebo for patients with resected, stage III BRAF V600E/K–mutant melanoma, said Axel Hauschild, MD, PhD.
It’s difficult to care for patients without that personal touch. One palliative care nurse offers solutions.
The FDA has accepted a Biologics License Application (BLA) for ropeginterferon alfa-2b (P1101) for use as a treatment for patients with polycythemia vera (PV) in the absence of symptomatic splenomegaly, according to PharmaEssentia Corporation, the manufacturer of the novel pegylated interferon.
The FDA has granted a priority review designation to a biologics license application (BLA) for the investigational, humanized monoclonal antibody naxitamab (Danyelza) for the treatment of patients with relapsed/refractory high-risk neuroblastoma.
Patients participating on phase I clinical trials could benefit from more integration of palliative care.
The CD71-directed probody-drug conjugate (PDC) of monomethyl auristatin E (MMAE) CX-2029 showed tolerability and antitumor activity in patients with advanced cancer, according to findings from the first-in-human phase 1/2 PROCLAIM-CX-2029 trial (NCT03543813) that were presented during the 2020 ASCO Virtual Scientific Program.
Infigratinib was found to demonstrate clinical activity in patients with metastatic urothelial carcinoma, regardless of what line of therapy it was administered, according to results of a retrospective analysis presented at the 2020 ASCO Virtual Scientific Program.
When patients call their nurses regarding adverse events, they could avoid hospitalizations – and higher costs – according to a recent study.
Each month, we take a look back at the most popular Oncology Nursing News® stories. Here are the top 5 stories from May 2020.
Relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone (T)-suppression through 48 weeks, fast T-recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer.
Pediatric precision oncology in a real-world, multinational setting is feasible. For the subgroup of children with very high priority level targets, the INFORM registry provided therapeutic opportunities and new diagnostic information.
