AstraZeneca ends month with two pieces of news
AstraZeneca has ended the month with more positive news on Tagrisso, that had previously been approved in China under its Priority Review, as it achieved FDA approval in a particular indication of non-small cell lung cancer (NSCLC). Beyond this, AstraZeneca also announced that it had sold the commercial rights to Zoladex, in the US and Canada, to TerSera Therapeutics for $250 million – with a potential further $70 million possible in milestone payments.
Tagrisso will be available for patients with metastatic epidermal growth factor receptor NSCLC, in cases where the EGFR T790M mutation is detected by an FDA approved test. The approval comes after the drug had received Accelerated Approval after positive clinical trials results.
The Phase 3 AURA3 trial displayed that Tagrisso improved progression-free survival from 4.4 months, with platinum-based doublet chemotherapy, to 10.1 months. The treatment is administered in once-daily 80mg tablets.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “By following the science, we aim to turn lung cancer into a chronic, manageable disease for patients and this milestone brings us one step closer to that ambition. The FDA’s full approval reinforces the potential of Tagrisso to become the standard of care for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer whose disease has progressed on or after first-generation EGFR-TKI therapy.”
The boost in patient numbers receiving Tagrisso comes alongside the previously mentioned divestment of commercial rights to TerSera. AstraZeneca will see its revenue boosted by sales payments in the ‘mid-teen’ percent of sales, on top of a potential $320 million payment.
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