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Oncology Practice Insider

ASCO’s Oncology Practice Insider provides the latest news, information, and educational tools to assist with the successful management of oncology practice and the delivery of high quality patient care. OPI offers updates on ASCO programs, services, and cancer-related health policy, Medicare news, and billing and coding best practices. To sign up for the biweekly Oncology Practice Insider newsletter, please complete this form.

Date
On December 14, 2018, the Food and Drug Administration approved Herzuma (trastuzumab-pkrb, Celltrion Inc.) as a biosimilar to Herceptin (trastuzumab, Genentech Inc.) for patients with HER2-overexpressing breast cancer. Read more. 
On December 14, 2018, the Food and Drug Administration approved romiplostim (NPLATE®, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Read more.
On December 6, 2018, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. Read more. 
On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI®, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.
On November 28, 2018, the Food and Drug Administration approved Truxima (rituximab-abbs, Celltrion Inc.) as the first biosimilar to Rituxan (rituximab, Genentech Inc.) for patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Read more. 
The FDA recently announced new changes to expand and update the Expanded Access (EA) program, which allows very ill patients access to experimental treatments outside of clinical trials. The most recent updates include:
On November 20, 2018, the Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Read more. 
On November 21, 2018, the Food and Drug Administration granted accelerated approval to venetoclax (VENCLEXTA®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Read more.