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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.

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On April 12, 2019, the Food and Drug Administration granted accelerated approval to erdafitinib (BALVERSA™, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
On April 11, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.
The Reagan-Udall Foundation for the U.S. Food and Drug Administration has added a new guide for companies regarding use of the Expanded Access Navigator. This guide is intended to provide small and emerging biopharmaceutical companies with assistance in understanding the procedures for expanded access, developing an expanded access policy for their company, and responding to requests for single-patient expanded access.
The Workshop on Development of Tissue-Agnostic, Biomarker-Based Indications, cohosted by ASCO, FDA, and Friends of Cancer Research, is now open for registration. The April 26 full-day event aims to bring together members of various sectors to identify clinical trial designs and strategies that can accelerate drug development based on biomarkers that are agnostic to tumor types. Learn more and register.
The U.S. Food and Drug Administration is alerting health care professionals, oncology clinical investigators and patients about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma based on data from a clinical trial. Venclexta is not approved for the treatment of multiple myeloma. Read more. 
On March 18, 2019, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Read more. 
On March 8, 2019, the Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ®, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test.
Registration is open for the 4th Annual FDA Clinical Outcome Assessments in Cancer Clinical Trials (COA-CCT) Workshop, which will take place July 12 at the FDA White Oak Campus in Silver Spring, Maryland. The one-day workshop, co-hosted by ASCO and the FDA, brings together international regulators, payers, industry, academia, and patients to advance the science of clinical outcome assessments. Learn more and register.