Priority Review Granted to Trastuzumab Deruxtecan for HER2+ Metastatic Gastric Cancer
October 29th 2020The FDA has accepted and granted a priority review designation to a supplemental biologics license application for the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu) for use in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
RAF Inhibitor Plus Cobicistat Is Promising in BRAF+ Refractory Solid Tumors
October 27th 2020PLX8394, a next-generation BRAF inhibitor, in combination with cobicistat (Tybost) was found to demonstrate encouraging clinical activity with an acceptable safety profile in patients with BRAF-mutated, refractory solid tumors, according to results from a phase 1/2 trial (NCT02428712) presented during the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Therapeutics.
Off-the-Shelf CAR T-Cell Product CTX100 Promising in Relapsed/Refractory CD19+ B-Cell Malignancies
October 26th 2020The investigational wholly-owned allogeneic chimeric antigen receptor T-cell therapy CTX110 demonstrated dose-dependent efficacy and responses in patients with relapsed/refractory CD19-positive B-cell malignancies.
Afatinib Efficacious in EGFR+ NSCLC With Uncommon Mutations, Regardless of Ethnicity
October 25th 2020Afatinib (Gilotrif) was found to be effective when used in Asian and non-Asian patients with non–small cell lung cancer (NSCLC) with major uncommon and compound EGFR mutations, irrespective of ethnicity, according to results from a pooled analysis presented during the 2020 IASLC North America Conference on Lung Cancer.
Expert Talks Pembrolizumab for TMB-High Tumors
October 24th 2020The FDA approval of pembrolizumab (Keytruda) for use in select adult and pediatric patients with unresectable or metastatic solid tumors that are tumor mutational burden (TMB)-high, has both generated a lot of excitement and been hotly debated, according to Vivek Subbiah, MD.
FDA Grants Priority Review to Adjuvant Osimertinib for EGFR-Positive NSCLC
October 21st 2020The FDA has granted osimertinib (Tagrisso) a priority review designation to a supplemental new drug application for the adjuvant treatment of patients with early-stage EGFR-mutated non–small cell lung cancer (NSCLC) following complete tumor resection with curative intent.
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.