The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
FDA Grants Fast Track Status to Padeliporfin ImPACT for Upper-Tract Urothelial Cancer
January 18th 2021January 18, 2021 — The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer.
Next-Generation AR Inhibitors Retain their Role in Nonmetastatic CRPC
January 18th 2021Despite the availability of next-generation PET imaging modalities that can detect metastasis earlier, apalutamide, enzalutamide, and darolutamide remain the standard of care for patients with nonmetastatic castration-resistant prostate cancer who have a prostate-specific antigen doubling time of less than 10 months.
Pembrolizumab Induces Antitumor Activity in Previously Untreated HCC
January 18th 2021Single-agent pembrolizumab demonstrated durable antitumor activity among patients with treatment-naïve hepatocellular carcinoma, suggesting that the checkpoint inhibitor may have additional utility in this space, according to findings from a phase 2 trial presented during the 2021 Gastrointestinal Cancers Symposium.
Second-Line Pembrolizumab Has Maintained Survival Benefit in Advanced HCC
January 18th 2021January 17, 2021 - Pembrolizumab demonstrated maintained numerical improvements in overall survival and progression-free survival compared with placebo in patients with previously treated advanced hepatocellular carcinoma.
Infigratinib Shows Promising Anticancer Activity in Chemo-Refractory, FGFR2+ Cholangiocarcinoma
January 17th 2021January 17, 2021 - Infigratinib was found to be associated with encouraging clinical activity with a manageable safety profile in patients with chemotherapy-refractory cholangiocarcinoma whose tumors harbor FGFR2 fusions.
Ivosidenib Induces OS Benefit in Advanced IDH1+ Cholangiocarcinoma
January 17th 2021January 17, 2021 — Ivosidenib tablets led to a 21% reduction in the risk of death compared with placebo in previously treated patients with IDH1-mutant cholangiocarcinoma, according to the final overall survival analysis of the phase 3 ClarIDHy trial.
TAS-102 Plus Bevacizumab Improves OS in mCRC Ineligible for Intensive Therapy
January 17th 2021January 16, 2021 - Trifluridine/tipiracil, when used in combination with bevacizumab, led to an improvement in overall survival over capecitabine/bevacizumab in the frontline treatment of patients with unresectable metastatic colorectal cancer who are not eligible for standard chemotherapy.
Addition of Pembrolizumab to Chemo Does Not Negatively Impact QoL in Patients With Esophageal Cancer
January 16th 2021January 16, 2021 - Health-related quality of life during an 18-week period proved to be similar over for patients with esophageal cancer treated with either pembrolizumab or placebo added to chemotherapy.
Frontline Pembrolizumab Improves PFS2, HRQoL in MSI-H/dMMR mCRC
January 16th 2021January 16, 2021 - Frontline use of pembrolizumab monotherapy significantly improved progression-free survival, while demonstrating superior safety, compared with chemotherapy in patients with microsatellite-instability high/mismatch repair deficient metastatic colorectal cancer.
Frontline Bemarituzumab/mFOLFOX6 Combo Improves Survival in Advanced FGFR2b+ Gastric/GEJ Cancer
January 16th 2021Bemarituzumab combined with mFOLFOX6 demonstrated a 56% reduction in the risk of disease progression or death compared with placebo and mFOLFOX6 as a frontline treatment in select patients with FGFR2b-positive advanced gastric or gastroesophageal junction adenocarcinoma.
Lenvatinib and Pembrolizumab Combination Safe, Effective For Multiple Gastrointestinal Cancer Types
January 15th 2021The combination of the anti-angiogenic multikinase inhibitor lenvatinib plus the anti-PD-1 antibody pembrolizumab demonstrated promising antitumor activity and a manageable safety profile in previously treated patients with advanced gastric cancer, advanced metastatic microsatellite instability-high or mismatch repair colorectal cancer, and advanced biliary tract cancers
FDA Approves Trastuzumab Deruxtecan for HER2+ Metastatic Gastric/GEJ Cancer
January 15th 2021January 15, 2021- The FDA has approved fam-trastuzumab deruxtecan-nxki for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a previous trastuzumab-based regimen.
FDA Approves Subcutaneous Daratumumab Plus VCd for Newly Diagnosed Light-Chain Amyloidosis
January 15th 2021January 15, 2021 - The FDA has approved daratumumab and hyaluronidase-fihj, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light-chain amyloidosis.
Anlotinib Induces PFS Benefit in RAS/BRAF Wildtype+ mCRC
January 15th 2021January 15, 2021 - Anlotinib, a multitarget kinase inhibitor, was found to significantly improve progression-free survival with a manageable safety profile when used in Chinese patients with refractory metastatic colorectal cancer.