Other Updates

FDA approves new dosing regimen for pembrolizumab

Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA, Merck) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen. April 28, 2020.

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-dosing-regimen-pembrolizumab

BAVENCIO dosage modification

On October 19, 2018, the FDA approved modification to the Recommended Dosage section of the PI for BAVENCIO as follows:

 “The recommended dosage of BAVENCIO is 800mg administered as an intravenous infusion over 60 minutes every 2 weeks until diseases progression or unacceptable toxicity.”

Please  refer to the Full Prescribing Information for BAVENCIO  for complete Dosage and Administration information.

NOTE:   There is no change to how BAVENCIO is supplied.  BAVENCIO is supplied as a single-dose vial of 200mg/10mL (20mg/mL) individually packed (11-digit NDC is 44087-3535-01). 

IMFINZI® (durvalumab) is the first immunotherapy to demonstrate significant overall survival benefit in unresectable, Stage III lung cancer

IMFINZI reduced the risk of death by nearly one-third compared to placebo in the Phase III PACIFIC trial

Updated data reaffirm unprecedented improvement in progression-free survival of more than 11 months

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of IMFINZI® (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine. September 25, 2018

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2018/imfinzi-durvalumab-is-the-first-immunotherapy-to-demonstrate-significant-overall-survival-benefit-in-unresectable-stage-iii-lung-cancer-09252018.html#!

Genomic Health Expands Offering to Prostate Cancer Patients with Launch of Oncotype DX® AR-V7 Nucleus Detect™ Test to Predict Treatment Response in Metastatic Disease

New Liquid Biopsy Test Helps Physicians Select Most Effective Treatment, Prolonging Lives of Men with Metastatic Castration-resistant Prostate Cancer

REDWOOD CITY, Calif., Feb. 26, 2018 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced the U.S. commercial launch of the Oncotype DX^® AR-V7 Nucleus Detect™ test. The first and only liquid biopsy test of its kind, the Oncotype DX AR-V7 Nucleus Detect test was developed by Epic Sciences to help prolong the lives of men with metastatic castration-resistant prostate cancer (mCRPC) by accurately detecting a splice variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTCs). Knowledge of a patient's AR-V7 status enables physicians to confidently decide whether men treated with an androgen receptor-signaling inhibitor (ARSI) therapy, such as enzalutamide and abiraterone, need to start another type of ARSI or switch to chemotherapy.