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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 March 27, 2020, the Food and Drug Administration approved durvalumab (IMFINZI®, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). Read more. 
The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
On March 10, 2020, the Food and Drug Administration granted accelerated approval to the combination of nivolumab and ipilimumab (OPDIVO® and YERVOY®, Bristol-Myers Squibb Co.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read more. 
The Center for Radiologic Health (CDRH) released a Letter to Health Care Providers on Surgical Mask and Gown Conservation Strategies. The letter is an effort to assist health care organizations and personnel with recommended conservation strategies for various supply levels of surgical masks and gowns during the COVID-19 outbreak. Please share this information with your colleagues and other organizations and to report potential or actual supply issues.
Statement By American Society of Clinical Oncology (ASCO) President Howard A. “Skip” Burris III, MD, FACP, FASCO “We commend the U.S. Food and Drug Administration (FDA) for releasing draft guidance to encourage inclusion of older adults in clinical trials of drugs for the treatment of cancer. We thank Richard Pazdur, MD, director of the FDA Oncology Center of Excellence, for his leadership on this important issue.
On February 25, 2020, the 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. Read more. 
On January 23, 2020, the Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK™, Epizyme, Inc.) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Read more. 
On January 9, 2020, the Food and Drug Administration approved avapritinib (AYVAKITTM, Blueprint Medicines Corporation) for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations. Read more.