AstraZeneca’s lung cancer drug Tagrisso has been granted full approval by the US Food and Drug Administration.
AstraZeneca’s said the FDA had approved Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy.
AstraZeneca said Tagrisso was the first and only approved medicine in the US indicated for NSCLC patients who have tested positive for the EGFR T790M mutation, and efficacy data suggest it may be a new standard of care for these patients.
AstraZeneca also announced that it has completed the agreement with TerSera Therapeutics LLC for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada.
Zoladex is an injectable luteinising hormone-releasing medicine, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders.
It was first approved in the US and Canada in 1989.
Under the terms of the agreement, AstraZeneca has received a payment of $250 million from TerSera for the commercial rights to the medicine in the US and Canada.
AstraZeneca said that as it would maintain a significant ongoing interest in Zoladex in the US and Canada, the payment would be reported as would Revenue in the company’s financial statements, and will be booked in the first quarter of 2017. AstraZeneca said it would receive future sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of sales.
AstraZeneca said it would also manufacture and supply Zoladex to TerSera, providing a further source of ongoing income from Zoladex in the US and Canada.
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