Nivatrotamab Granted Orphan Drug Status for Pediatric Neuroblastoma
October 8th 2020The FDA has granted an orphan drug designation and rare pediatric disease designation to the bispecific antibody nivatrotamab for the treatment of patients with neuroblastoma, according to an announcement from Y-mAbs Therapeutics, Inc.
FDA Gives Refusal to File Letter for Omburtamab to Treat Pediatric Metastatic Neuroblastoma
October 7th 2020Following preliminary review of the data submitted for the agent, the regulatory agency determined that certain portions of the Chemistry, Manufacturing, and Control (CMC) module and the Clinical module of the application require further detail. However, no non-clinical data have been requested.
Lutathera Is Tolerable for NETs, According to Long-Term Toxicity Data
October 5th 2020Longer-term data demonstrated that treatment with the radiopharmaceutical Lutathera (lutetium-177 dotatate) continued to show low rates of toxicity among patients with somatostatin receptor–positive neuroendocrine tumors (NETs), said Edward M. Wolin, MD, who added that the positive findings open the potential for novel combinations with the agent.
Germline Testing for Lynch Syndrome: More Important Than Ever
October 4th 2020With the emergence of several targeted treatments that have shown efficacy in individuals with germline pathogenic variants, specifically in DNA mismatch repair, the need for germline genetic testing has become even more pronounced.
FDA Approves Nivolumab Plus Ipilimumab for Malignant Pleural Mesothelioma
October 3rd 2020The FDA approved nivolumab (Opdivo) plus ipilimumab (Yervoy) for the frontline treatment of adults with unresectable, malignant, pleural mesothelioma (MPM), according to Bristol Myers Squibb, the manufacturer of the immunotherapy agents.
Gender Disparities in Cancer Care: What Can We Do?
October 2nd 2020To address such disparities, it is important for institutions to embrace and promote the fostering of an inclusive culture and environment for health care professionals of all races and genders, and to adequately equip women specifically with the tools they need to achieve success in the field.
FDA Recommends Black-Box Warning on Breast Implants
September 30th 2020Makers of breast implants should supplement their labeling to include a boxed warning about health problems that can arise from the devices, along with a patient decision checklist that highlights those concerns, according to final guidance issued today by the Food and Drug Administration.
Immunotherapy Combos in Advanced Nonsquamous NSCLC: What Does the Data Say?
September 29th 2020The paradigm of advanced nonsquamous non–small cell lung cancer (NSCLC) is now one that necessitates discussions regarding the use of combination chemoimmunotherapy, combination immunotherapy, and single-agent immunotherapy, explained Jonathan Dowell, MD.
FDA Approval Sought for TLX591-CDx for Prostate Cancer Imaging
September 28th 2020A new drug application has been submitted to the FDA for TLX591-CDx, a radiopharmaceutical product that targets prostate-specific membrane antigen, for the imaging of prostate cancer through the use of positron emission tomography.
Investigational CAR T-Cell Product Plus Immunotherapy Is Active in DLBCL
September 26th 2020The investigational CAR T-cell product AUTO3 in combination with pembrolizumab was found to have a tolerable safety profile and elicit durable complete responses in patients with relapsed/refractory diffuse large B-cell lymphoma.
DKN-01 Gets Fast-Track Status for Gastric and GEJ Cancer
September 25th 2020The FDA has granted a fast track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors have high DKK1 expression, who have progressed on or after a fluoropyrimidine- and platinum-containing chemotherapy, and HER2/neu targeted therapy, if appropriate.
FDA Grants Priority Review to Crizotinib for Pediatric ALK-Positive ALCL
September 24th 2020The FDA has granted a priority review to a supplemental new drug application (sNDA) for crizotinib (Xalkori) in the treatment of pediatric patients with ALK-positive relapsed/refractory systemic anaplastic large cell lymphoma (ALCL), according to an announcement from Pfizer, Inc.
Molecularly-Guided Therapy Improves Outcomes in Kidney Cancer
September 22nd 2020Findings from the noncomparative, phase 2, biomarker-driven BIONIKK trial demonstrated clinical evidence to support the use of molecularly-directed frontline therapy as means to enrich responses in patients with metastatic clear cell renal cell carcinoma (ccRCC).
Surufatinib Shows PFS Benefit in Advanced Pancreatic NETs
September 21st 2020The novel VEGFR, FGFR, and CSF-1R inhibitor surufatinib yielded a statistically significant and clinically meaningful progression-free survival (PFS) benefit compared with placebo in patients with advanced pancreatic neuroendocrine tumors (pNETs), according to results from the randomized phase 3 SANET-p trial that were presented virtually during the 2020 ESMO Congress.
High-Risk Biology Associated With Poorer Outcomes in MCL
September 20th 2020Patients with mantle cell lymphoma (MCL) who have high-risk biology, including blastoid variant, a Ki-67 score of at least 30%, or high p53 expression, had a significantly shorter failure-free and overall survival (OS), according to results of a retrospective trial.
Novel Molecule Enhances Immunotherapy Response in CRC, According to Early Data
September 19th 2020The advent of immunotherapy has revolutionized multiple areas of cancer treatment, said Timothy Cragin Wang, MD, who added that the transformative potential of the modality has been mild at best in the field of colorectal cancer (CRC).
Christie Santure, B.S.N., RN, OCN, Wins CURE's 2020 Extraordinary Healer Award for Oncology Nursing
September 18th 2020At a virtual event Sept. 17, CURE® also named Elizabeth Farrat, B.S.N., RN, CCRN-K, the winner of its first-ever Finest Hour Award for selfless achievements in care during the COVID-19 pandemic.