Nivolumab Plus Cabozantinib Gets Priority Review for Advanced RCC Treatment
October 20th 2020The FDA has granted a priority review designation to a supplemental biologics license application and supplemental new drug application for nivolumab (Opdivo) plus cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma.
Pediatric Osteosarcoma and Pathogenic TP53 Variants
October 19th 2020TP53 was found to be the only gene with a germline de novo pathogenic or likely pathogenic variant in pediatric patients with osteosarcoma, according to findings from the Children’s Oncology Group that were published in JCO Precision Oncology.
Clinical Trials Will Change the Metastatic Pancreatic Cancer Landscape
October 16th 2020Clinical trials should not be viewed as a last resort for patients with metastatic pancreatic cancer, explained Allyson Ocean, MD, who added that even frontline standards of care should be considered after exhausting all available study options.
FDA Approval Sought for Pacritinib to Treat Myelofibrosis With Severe Thrombocytopenia
October 14th 2020A rolling submission of a new drug application (NDA) for the JAK2/FLT3 inhibitor pacritinib has been initiated for patients with myelofibrosis and severe thrombocytopenia defined as platelet counts of less than 50,000 μL.
Start Sexual Health Discussions Early On, Says Expert
October 10th 2020Maintaining sexual function is often low on the list of priorities for a woman recently diagnosed with a gynecologic cancer, but raising the subject early in her treatment course may make the patient more willing to engage in a discussion as her care progresses, according to Don S. Dizon, MD, who specializes in survivorship issues.
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.