FDA Approves Pembrolizumab for TMB-High Solid Tumors
June 17th 2020The 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.
FDA Expands Gardasil 9 Approval for HPV-Related Cancers
June 15th 2020On 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.
FDA Approves Pegfilgrastim Biosimilar
June 11th 2020The 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.
Upfront 4-Drug Regimen Is Tolerable in Lung Cancer Treatment
June 11th 2020The 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 .
Acalabrutinib Shows Promise for Frontline CLL Treatment
June 8th 2020Long-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.
Margetuximab Granted Orphan Drug Status for Gastric Cancer
June 7th 2020The 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.
Dabrafenib/Trametinib Brings Remission-Free Survival Advantage to Melanoma Subset
June 6th 2020Five-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.
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.