Please login to the form below

Not currently logged in
Email:
Password:

Novartis' Zykadia prepped to take on Xalkori in Europe

The Swiss pharma giant’s drug will treat ALK-positive NSCLC patients

NovartisMore patients in Europe should be eligible for treatment with Novartis' Zykadia after the EMA's advisory committee backed first-line use of the ALK inhibitor.

If the EMA follows the advice of the Committee for Medicinal Products for Human Use (CHMP) - as it generally does - Zykadia (ceritinib) should be cleared for use as a monotherapy in previously-untreated patients with ALK-positive non-small cell lung cancer (NSCLC) - allowing it to compete head-to-head with Pfizer's big-selling Xalkori (crizotinib).

Previously Zykadia was only approved for use in ALK-positive NSCLC patients whose disease had progressed despite earlier treatment with Xalkori, which is the dominant player in the ALK inhibitor category with sales of $561m last year. Zykadia is the first of a new series of ALK inhibitors to claim approval for first-line NSCLC in the EU, and is also going through a priority review in the US after being filed there towards the end of last year.

The CHMP's positive opinion is based on the results of the ASCEND-4 study, which showed that Zykadia treatment reduced progression-free survival by 45% compared to patients treated first-line with standard chemotherapy. Patients achieved median progression-free survival (PFS) of 16.6 months and 8.1 months respectively, and in those with brain metastases the drug did even better with a PFS of 26 months versus 8 months for chemo.

Zykadia could see tough competition in NSCLC from Roche's Alecensa (alectinib), which bested Xalkori in the head-to-head ALEX trial reported last month adding to growing momentum for Roche's drug, which outsold Zykadia last year despite coming to market later.

Alecensa is already approved as a second-line therapy after Xalkori in the US and Europe, and has approval for first-line use in Japan where it is sold by Chugai. Meanwhile Takeda has just picked up its first approval for Alunbrig (brigatinib) - an ALK inhibitor acquired as part of its $5.2bn acquisition of Ariad - adding further competition in the market.

Takeda reckons Alunbrig is a best-in-class drug with sales potential of $1bn or more, and has a head-to-head trial with Xalkori ongoing to try back up that claim.

Cancer specialists are already discussing among themselves the best order in which to use the drugs - or even use in combination - in order to minimise resistance and extend PFS. Additionally the ALK inhibitors are all being tested in combination with other drugs - including new immuno-oncology agents - and the outcome of those studies could have a dramatic impact on their fortunes.

Article by
Phil Taylor

22nd May 2017

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Lucid Group Communications Limited

We are industry-leading thinkers when it comes to education. We use the latest academic thinking on the psychology of behaviour...

Latest intelligence

Australian Flu and the dilemma of naming diseases
...
Wearables and Healthcare
What place do wearables have in affecting actual patient health outcomes and can they contribute to the NHS’s sustainability agenda? Or are they just the latest fad?...
What does a future-proof rep look like?
Businesses can no longer afford to push ahead with the traditional Key Account Management model....

Infographics