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FDA approvals in July:
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This one-hour interactive, online CME/CMLE module is designed to help pathologists and laboratory professionals gain a deeper scientific understanding of recent advances in the diagnosis and management of HER2-positive and HER2-low breast cancer.
To claim CME credit for this course, please register at https://store.ascp.org/productlisting/productdetail?productId=123811419&_ga=2.269259641.929308495.1598834085-509862140.1542376895 Supported by an independent educational grant from Daiichi Sankyo, Inc. Food and Drug Administration approved isatuximab-irfc (SARCLISA, sanofi-aventis U.S. LLC) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. More Information. March 2, 2020
Food and Drug Administration approved neratinib (NERLYNX, Puma Biotechnology, Inc.) in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. More Information. February 25, 2020
This online course will allow pathologists, laboratory professionals, and cancer clinicians to experience a virtual cancer committee discussion that explores ways to improve biomarker testing processes and addresses the complex challenges associated with identifying and managing immune-mediated adverse reactions. To claim CME credit for this course, go to: https://store.ascp.org/productlisting/productdetail?productId=120806280 On October 23, 2019,the Food and Drug Administration approved niraparib (ZEJULA, Tesaro, Inc.) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status. HRD is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability in patients with disease progression greater than six months after response to the last platinum-based chemotherapy.
Efficacy was investigated in 98 patients with advanced ovarian cancer with HRD-positive tumors in the single-arm QUADRA (NCT02354586) trial. Patients were treated with three or more prior lines of chemotherapy. Patients with prior exposure to PARP inhibitors were excluded. Patients without BRCA mutations must have progressed at least six months after the last dose of platinum-based therapy. HRD-positive status was determined using the Myriad myChoice CDx as either tumor BRCA mutated (tBRCAm) (n=63) and/or a genomic instability score (GIS) ≥ 42 (n=35). All patients received 300 mg of niraparib once daily until disease progression or unacceptable toxicity. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-hrd-positive-advanced-ovarian-cancer Pathway maps are a quality improvement tool for the Ontario cancer system. They represent evidence-based best practice for the management of patients during a specific phase of their cancer experience. https://www.cancercareontario.ca/en/pathway-maps For example, for lung cancer, the CCO has published the following clinical pathway maps:
FDA approved daratumumab (DARZALEX, Janssen) for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant (ASCT). September 26, 2019.
FDA approved apalutamide (ERLEADA, Janssen Biotech, Inc) for patients with metastatic castration-sensitive prostate cancer (mCSPC). Apalutamide was initially approved in 2018 for patients with non-metastatic castration-resistant prostate cancer. September 17, 2019 FDA granted accelerated approval to the combination of pembrolizumab (KEYTRUDA, Merck) plus lenvatinib (LENVIMA, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. September 17, 2019 Currently, there are several different molecular testing methods that may be used to detect NTRK gene fusions. NGS can be used to identify NTRK gene fusions as well as other actionable alterations. It is important to know whether the NGS assay used has the capacity to detect NTRK gene fusions.
According to the drug manufacturers, the following NGS testing platforms use assays that can detect NTRK gene fusions:
NGS, next-generation sequencing; NTRK, neurotrophic receptor tyrosine kinase. |