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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 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. 
On January 8, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Read more. 
Save the date for this 2-part webinar on FDA audit readiness, which will take participants on a journey through the FDA inspection process. The webinars will share experiences to make FDA inspections less daunting. The first webinar, taking place February 13 will include reflections from FDA and a principal investigator, who will share case studies and lessons learned on site selection and the investigator role. The second webinar, date to be announced, will offer strategies for effective pre-audit preparation and post-audit follow-up.
On December 27, 2019, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.