AbbVie files sNDA for Imbruvica

14 September 2015

US drug major AbbVie (NYSE: ABBV) submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration requesting a new indication for Imbruvica (ibrutinib).

The application is based on the randomized, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) trial assessing the use of Imbruvica versus chlorambucil in treatment-naive chronic lymphocytic leukemia (CLL) patients aged 65 years or older.

AbbVie announced top-line findings from the trial in June 2015 showing that Imbruvica improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naive patients with CLL. Imbruvica is jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ).

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK