FDA Approves Frontline Pembrolizumab for MSI-H/dMMR Metastatic CRC
June 30th 2020The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.
FDA Approves Phesgo, an In-Home Breast Cancer Treatment
June 29th 2020The FDA approved subcutaneous Phesgo – a combination of pertuzumab (Perjeta), trastuzumab (Herceptin), and hyaluronidase–zzxf – for the treatment of patients with metastatic HER2-positive breast cancer, as well as early-stage HER2-positive breast cancer, as selected by an FDA-approved companion diagnostic test.
PIK3A-Mutant Breast Cancer Shows Increased Sensitivity to PI3Kα Inhibition
June 27th 2020Patients with breast cancer who harbor multiple PIK3A-mutant tumors achieved a higher clinical benefit from PI3Kα inhibition compared with single mutant tumors according to response analysis data from the SANDPIPER trial.
Pembrolizumab Shows Modest Activity in Advanced Ovarian, Gynecologic Cancers
June 24th 2020Pembrolizumab (Keytruda) demonstrated modest clinical activity in patients with advanced recurrent ovarian cancer, according to final results of the phase 2 KEYNOTE-100 trial that were presented during the 2020 ASCO Virtual Scientific Program.
COVID-19 Pandemic Highlights the Importance of Real World Data in Oncology
June 24th 2020The ongoing coronavirus disease 2019 (COVID-19) pandemic has magnified the value of real-world data (RWD) in oncology. The FDA is presently spearheading several initiatives aimed at refining the role of RWD in cancer care to guide clinical trial development, procure answers to pressing clinical questions, and support regulatory decisions for in vitro diagnostics.
Immunotherapy/Chemotherapy Regimen Improves Lung Cancer Outcomes, Regardless of Biomarker Status
June 23rd 2020The combination of atezolizumab (Tecentriq) plus carboplatin/etoposide continued to demonstrate an improvement in overall survival (OS) versus chemotherapy alone as a frontline treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), regardless of PD-L1 and blood tumor mutational burden (bTMB) status.
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.