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AZ sets price of new lung cancer drug Tagrisso

Price tag of $150,000 per year given

AstraZeneca's just-approved lung cancer therapy Tagrisso will cost around $150,000 per year at wholesale acquisition prices in the US, according to the firm.

Tagrisso (omisertinib; formerly AZD9291) bagged an early FDA approval on Friday for the treatment epidermal growth factor receptor (EGFR) positive non-small cell lung cancer (NSCLC) patients whose tumours carry the T790M mutation.

The drug is a third-generation EGFR inhibitor, which is designed to overcome resistance to other drugs in the class such as Roche/Astellas' $2bn-a-year Tarceva (erlotinib), AZ's Iressa (gefitinib) and Boehringer Ingelheim's Giotrif (afatinib).

It is the first drug to be approved for marketing in patients with T790M-positive NSCLC who have progressed on or after EGFR inhibitor therapy.

A fifth of patients with NSCLC have tumours that are resistant to first-generation EGFR inhibitors from the outset, and the effects tend to be short-lived even in responders. Nearly all tumours eventually develop resistance within 10 to 12 months, even when switched to second generation drug Giotrif.

The $12,750 per month cost of the third-generation EGFR inhibitor seems in line with the hefty price tags being attached to most of new lung cancer drugs, including ALK inhibitors such as Pfizer's Xalkori (crizotinib) and Novartis' Zykadia (ceritinib), according to a Reuters report.

AZ has high hopes for Tagrisso, predicting it will eventually become a $3bn-a-year product, thanks to the high incidence of lung cancer and the fact that many patients taking EGFR-based therapy will eventually be eligible for treatment.

All told, nearly two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR inhibitor develop the T790M resistance mutation.

Clovis setback

Prospects for the drug have also been enhanced by a delay to a drug in the same class in development at Clovis Oncology. The FDA has asked for more data on the drug - called rociletinib - which could potentially hold up the programme by several months.

Clovis' shares have lost three quarters of their value in the 48 hours since the company announced the delay, which will give AZ time to consolidate its position in the market as well as allow other rivals such as Boehringer Ingelheim's BI 1482694 to catch up.

The FDA's problems with the dataset for rociletinib hinge on the number of unconfirmed versus confirmed responses to treatment, raising questions about the level of efficacy seen with the drug.

Specifically, the number of unconfirmed responses that have converted to a confirmed response was lower than expected and the agency's reviewers have said they will focus exclusively on confirmed responses.

The regulator was scheduled to deliver a verdict on the marketing application by the end of March 2016, a little ahead of the European Medicines Agency (EMA) which is also reviewing the drug.

Article by
Phil Taylor

18th November 2015

From: Sales



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