Incyte’s Jakafi Gets Additional Claim Based On Patient-Reported Outcomes
Jakafi is the first approved treatment for myelofibrosis, a rare bone marrow cancer, but Incyte will also be able to claim efficacy against the symptoms of the disease thanks to data in labeling from a patient-reported outcomes tool.
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Patient-Reported Outcome Data Helps Dermira’s Hyperhidrosis Drug Qbrexza Win US FDA Nod
Co-primary endpoint was Axillary Sweating Daily Diary, a novel PRO instrument developed by Dermira with FDA input, assessed sweating severity and impact of sweating on a person’s daily activities; results complemented quantitative measure of sweat production in Phase III trials.
Regulatory Briefs: Ebola Trials Protocol, AstraZeneca Resubmits Iressa
FDA officials explain why randomized clinical trials of Ebola products are necessary and the Senate passes Ebola priority review voucher bill. Lilly/AstraZeneca start Alzeimer’s trial, Incyte gains new approval for Jakafi, Sunovion files for new use of Aptiom and AstraZeneca resubmits its once withdrawn lung cancer drug Iressa.
Patient-Reported Outcomes in Oncology: The Jakafi and Zytiga Exceptions
Oncology is the biggest area of biopharmaceutical R&D where patient-reported outcomes are not routinely collected during clinical trials. There are some good reasons why. Jakafi and Zytiga remain outliers oncology treatment with a PRO in the approved label.