GlaxoSmithKline’s Hycamtin receives first stage European approval

Drug giant GlaxoSmithKline (GSK) has announced that its lung cancer drug Hycamtin has received first stage approval from the European committee for human medicinal products (CHMP).

The CHMP’s positive response, which GSK says was made on the back of good results from three phase III trials, means that the firm can now seek full marketing approval within the EU.

Hycamtin is used for the treatment of relapsed small-cell lung cancer (SCLC). In one study it found that patients who took Hycamtin and received basic supportive care had their median survival rate raised to 25.9 weeks, compared to 13.9 weeks for those who simply received basic care.

“Hycamtin offers clinicians an important therapeutic option for patients with relapsed SCLC,” said Mikael von Euler of GSK. He said that the phase III studies show that “single-agent Hycamtin is active in relapsed SCLC.

“Furthermore, the Hycamtin versus best supportive care study has proven for the first time that treatment of relapsed SCLC in appropriate patients can offer symptom as well as survival benefit,” he added.

Hycamtin is already registered in the EU for the treatment of relapsed ovarian cancer.

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