EU gives nod to expanded label for AZ’s Tagrisso
AstraZeneca has scored another success with Tagrisso in Europe, by receiving an expanded marketing authorisation for Tagrisso in the first-line setting for patients with locally-advanced or metastatic non-small cell lung cancer, with activating epidermal growth factor receptor mutations.
The approval comes on the back of data from trials showed that Tagrisso was able to reduce risk of disease progression or death by 54% when compared against standard treatment.
The drug received the same approval in the US in April, alongside Brazil and Russia approvals; it is also awaiting a decision in Japan during the second quarter.
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “Today’s approval is an exciting advance in bringing a potential new standard of care to patients with EGFR-mutated NSCLC in the EU. This milestone is also a step forward for our Company, marking another regional approval for Tagrisso in the 1st-line setting.”
The recent approvals should see sales of the drug increase further, after it has already become the largest-selling medicine in AZ’s oncology profile during 2017 results; in this full year, the drug brought in $955 million in sales.
Expectations are that the drug could achieve peak sales of $3 billion.
It was initially approved to treat patients who developed the EGFR T790M resistance mutation but the company is working aggressively to expand indications by testing it as a combination treatment and adjuvant therapy.
AZ is relying on Tagrisso and immunotherapy, Imfinzi, to draw in sales for the company, after its first quarter results demonstrated the impact Crestor falling off-patent has had to its finances – as sales fell 38% on the drug and revenue fell by 4% across the board.
AstraZeneca has announced that it has launched Evinova, its new health-tech business, which it is …
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) …