Alberto Calvo-García, PharmG, and colleagues analyzed routinely-collected data to assess regorafenib in metastatic colorectal cancer.
FDA Approves FoundationOne Liquid CDx Assay for Identifying EGFR+ NSCLC Eligible for TKI Inhibitors
December 21st 2022The FDA has approved the FoundationOne Liquid CDx as a companion diagnostic for identifying patients with non-small cell lung cancer harboring EGFR mutations who may benefit from treatment with specific tyrosine kinase inhibitors.
FDA Accepts sBLAs for Enfortumab Vedotin/Pembrolizumab in Advanced or Metastatic Urothelial Cancer
December 21st 2022The FDA has set the Prescription Drug User Fee Act date for April 21, 2023 for each supplemental biologics license application of enfortumab vedotin-ejfv and pembrolizumab in urothelial carcinoma.
Recap: Selinexor, Carfilzomib, and Dexamethasone for Relapsed/Refractory Multiple Myeloma
December 20th 2022Joseph Mikhael, MD, and Hakan Kaya, MD, review key efficacy and safety data for the combination of selinexor, carfilzomib, and dexamethasone in R/R MM and discuss optimal dosing and adverse event management strategies for selinexor.
Expert Offers Considerations For Frontline Combination Therapies in Multiple Myeloma
December 20th 2022Ravi Vij, MD, MBA, offered additional information about the use of various regimens aimed to treat patients with high-risk, newly diagnosed multiple myeloma, that were read out at the 2022 ASH Annual Meeting.
SWOG S0777 Trial Proves VRd To Be Viable Option for Untreated Myeloma That Is Unintended for ASCT
December 20th 2022Ravi Vij, MD, MBA, discussed updated analyses of the phase 3 SWOG S0777 trial, supporting the use of bortezomib, lenalidomide, and dexamethasone in untreated patients with multiple myeloma who do not plan on receiving immediate autologous stem cell transplant.
Many Great Treatments Available for MCL But Questions About Sequencing Remain, Expert Says
December 18th 2022In a conversation during the 2022 American Society of Hematology Annual Meeting, an expert from the University of Texas MD Anderson Cancer Center, spoke to how treatments have improved for patients with mantle cell lymphoma.
FDA Requests Melphalan Flufenamide be Withdrawn From US Market
December 18th 2022The FDA has now requested that the manufacturer of melphalan flufenamide withdraw the multiple myeloma drug from the United States market months after the drug developer rescinded a letter voluntarily withdrawing the therapeutic.
China’s National Medical Products Administration Approves Naxitamab-gqgk for High-Risk Neuroblastoma
December 17th 2022Patients in China diagnosed with high-risk neuroblastoma can now receive treatment with naxitamab-gqgk, which was recently given the greenlight by the National Medical Products Administration.
European Commission Approves 177Lu Vipivotide Tetraxetan Plus ADT for Prostate Cancer Subset
December 17th 2022177Lu vipivotide tetraxetan becomes first targeted radioligand treatment approved by the European Commission for prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
FDA Approves First Gene Therapy for Non-Muscle Invasive Bladder Cancer
December 16th 2022Patients with high-risk Bacillus Calmette Guérin–unresponsive non-muscle invasive bladder cancer can now receive treatment with nadofaragene firadenovec-vncg—the first gene therapy—following its approval by the FDA.