All Articles
By Wayne Kuznar
Promising markers of response to immune checkpoint inhibition include tumor mutation burden (TMB) and genomic markers that reflect a disruption of the tumor immunity cycle, said Natalie Vokes, MD, MPhil, Medical Oncology Fellow, Dana-Farber Cancer Institute, Boston, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. Read More ›
By Wayne Kuznar
Ovarian cancers with BRCA mutations are less immunogenic than other DNA repair–deficient tumors. Targeting the DNA damage response using PARP inhibitors may help to improve the modest responses of ovarian cancer seen with single-agent immune checkpoint inhibitors, said Panagiotis A. Konstantinopoulos, MD, PhD, Director of Translational Research, Division of Gynecologic Oncology, Dana-Farber Cancer Institute, Boston, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. Read More ›
By Wayne Kuznar
Tumor expression of PD-L1 has consistently predicted response and survival outcomes in non–small-cell lung cancer (NSCLC), whereas the role of PD-L1 in immune cells is unclear, said Edward B. Garon, MD, Director, Thoracic Oncology Program, David Geffen School of Medicine, University of California, Los Angeles, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. Read More ›
On April 12, 2019, the FDA accelerated the approval of erdafitinib (Balversa; Janssen), a fibroblast growth factor receptor (FGFR) kinase inhibitor, for the treatment of adults with locally advanced or metastatic urothelial carcinoma and FGFR3 or FGFR2 genetic alterations, as detected by an FDA-approved test, whose disease progressed during or after ≥1 lines of platinum-containing chemotherapy, making it the first targeted drug to receive approval for this patient population. Read More ›
On April 19, 2019, the FDA accelerated the approval of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC). Keytruda has received previous FDA approval as a single agent or in combination with other agents for the treatment of many types of cancers. Read More ›
On April 19, 2019, the US Food and Drug Administration (FDA) approved a combination of pembrolizumab (Keytruda; Merck) plus axitinib (Inlyta; Pfizer) for the first-line treatment of patients with advanced renal-cell carcinoma (RCC), making it the first immunotherapy combination regimen approved for patients with this disease. Read More ›
In This Article:
- Another Approval for Keytruda and An Easing of Pregnancy Restrictions for Women Taking Soltamox
- FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox
On February 22, 2019, the FDA approved a new indication for trifluridine plus tipiracil (Lonsurf; Taiho Pharmaceuticals), an oral combination of a nucleoside metabolic inhibitor and a thymidine phosphorylase inhibitor for the treatment of patients with metastatic gastric or gastroesophageal junction adenocarcinoma who received ≥2 lines of chemotherapy regimens with a fluoropyrimidine, a platinum, a taxane or irinotecan, and, if appropriate, HER2/neu-targeted therapy. Read More ›
On February 28, 2019, the FDA approved a combination of the HER2/neu receptor agonist trastuzumab plus the endoglycosidase hyaluronidase-oysk (Herceptin Hylecta; Genentech) subcutaneous (SC) injection for adults with HER2-overexpressing breast cancer in the adjuvant setting, as part of a regimen with chemotherapy or as monotherapy after multimodality anthracycline-based therapy; and as first-line treatment for metastatic disease, in combination with paclitaxel, or as monotherapy after ≥1 chemotherapies in the metastatic setting. Read More ›
On March 1, 2019, the FDA accelerated the approval of atezolizumab (Tecentriq; Genentech) plus nab-paclitaxel (Abraxane; Celgene) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) and PD-L1 expression, as identified by an FDA-approved test. Tecentriq was previously approved for bladder cancer and for non–small-cell lung cancer. This is the first FDA approval of an immunotherapy for patients with metastatic TNBC. Read More ›