Puma catches fifth approval, hunts new indication for Nerlynx

5 September 2019

Two positive developments for Puma Biotechnology this week have lifted hopes for the potential of the firm’s sole product, the breast cancer therapy Nerlynx (neratinib).

As well as picking up its first approval in Latin America, the therapy has been granted Orphan Drug designation from the US Food and Drug Administration for the treatment of breast cancer patients with brain metastases.

While Nerlynx won approval in the USA for extended adjuvant treatment of HER2-positive early-stage breast cancer in 2017, it was initially rejected in Europe, amid a mixed view of its risk-benefit profile. The European Medicines Agency finally gave the nod in late 2018.

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