The drug can now be used as first line treatment in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin.
ES-SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.
The approval, based on trials demonstrating a statistically significant and clinically meaningful overall survival of patients, was recommended in July by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Farxiga in “unprecedented” performance
In a separate update, the FTSE 100 firm also revealed that its Farxiga drug candidate “demonstrated unprecedented reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease (CKD)”.
Phase III trials showed that the treatment reduced the worsening of renal function or risk of heart or kidney failure by 39% compared to placebo.
The tests were on patients with CKD at advanced stages, both with and without type-2 diabetes.
CKD is a progressive condition where kidneys stop working properly, affecting nearly 700mln people worldwide. The most common causes are diabetes, hypertension and glomerulonephritis (inflammation of kidney filters).
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