FDA Accepts BLA for Ropeginterferon Alfa-2b for PV Treatment
June 5th 2020The 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.
FDA Grants Naxitamab Priority Review for High-Risk Neuroblastoma
June 4th 2020The 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.
Novel Drug Appears Safe and Active for Advanced Solid Tumors
June 3rd 2020The 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 Is Active in Metastatic Urothelial Cancer
June 2nd 2020Infigratinib 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.
Relugolix May Become New Standard of Care for Advanced Prostate Cancer
June 1st 2020Relugolix (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.
International Pediatric Cancer Registry Can Improve Outcomes
May 31st 2020Pediatric 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.
FDA Approves Ramucirumab + Erlotinib for Firstline EGFR+ NSCLC
May 30th 2020The FDA has approved the combination of ramucirumab (Cyramza) and erlotinib (Tarceva) as a frontline treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.
FDA Approves Atezolizumab Plus Bevacizumab for Frontline Liver Cancer
May 29th 2020The FDA has approved the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Recent Chemotherapy May Increase COVID-19 Mortality Risk for Patients With Thoracic Cancer
May 29th 2020Chemotherapy administered within 3 months of a diagnosis of coronavirus disease 2019 (COVID-19) increased the risk of death in patients with thoracic cancer, according to findings from the global TERAVOLT Consortium registry.
FDA Grants CLR 131 Fast Track Status for 2 Rare Blood Cancers
May 28th 2020The FDA has granted a Fast Track designation to CLR 131 for use as a treatment for patients with lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM) who have received at least 2 prior treatment regimens.
When to Stop Immunotherapy in Metastatic Lung Cancer: Expert Weighs In
May 27th 2020Immunotherapy should be continued for up to 2 years in patients with metastatic lung cancer who are responding to the treatment, unless they experience disease progression or excessive toxicity, according to Gilberto de Lima Lopes, MD.
Ruxolitinib Discontinuation Worsens Myelofibrosis Outcomes, Highlighting Unmet Need
May 26th 2020A United States population-based outcome analysis of real-world patients with myelofibrosis who had discontinued ruxolitinib (Jakafi) demonstrated an increase in morbidity burden and identified the risk factors of survival outcomes, according to John O. Mascarenhas, MD.
sNDA Submitted to the FDA for Earlier Selinexor Treatment in Myeloma
May 21st 2020Karyopharm Therapeutics Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for the use of selinexor (Xpovio) as a treatment for patients with multiple myeloma following at least 1 line of prior therapy.
Guiding Nurses On HCC Management During The Era Of COVID-19
May 21st 2020This OncLive® webinar focused on the impact of COVID-19 on oncology nursing care for patients with hepatocellular carcinoma. We featured oncology nurse experts, Amy Hillsman, CRNP, and Abigail Smith, CRNP, discussing important topics and considerations for nurses and how they continue to provide the best care for their patients during this time.
FDA Approves Olaparib for mCRPC Subset
May 20th 2020The FDA has approved olaparib (Lynparza) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide (Xtandi) or abiraterone acetate (Zytiga).