AZ withdraws lung cancer drug from EU lead market

According to a recent  benefit assessment from the G-BA, the German health technology assessment body, data provided by the British drugmaker AstraZeneca did not provide evidence for an added value of the company’s 3rd generation NSCLC drug osimertinib (Tagrisso) vs reference treatment. As the evaluation forms the basis for price negotiations, AstraZeneca immediately withdrew Tagrisso from the German market, the pharmaceutical lead market in Europe. According to the DGHO, Tagrisso achieved an objective response rate of 60% in patients, who had become resistant to other EGFR inhibitors because they carry the so-called T790M mutation. Additionally, the targeted therapy is better tolerated than chemotherapy, the association stressed.

Both parties are in the right according to their own rules, the association said. But it is the lung cancer patients that are suffering the consequences.

As Tagrisso, which is prescribed after stratification with a companion diagnostics test, achieved Fast Track-, Breakthrough Therapy-, Priority Review- and Accelerated Approval-designation, only 400 patients were tested in pivotal studies leading to market authorisation in the US and the EU. While data were sufficient to prove safety and efficacy, they were not sufficient to prove added value according to German drug law AMNOG. AstraZeneca announced it will resubmit data, after results of an ongoing Phase III study due to be published in December, will be available.