GSK sees chemotherapy treatment receive positive EMEA opinion

GlaxoSmithKline (GSK) has announced that its oral Hycamtin (topotecan hard capsules) has received a positive opinion from the European Medicines Agency (EMEA) in support of possible marketing authorisation.

Topotecan capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Following the recommendation, GSK has stated its expectation that final approval for marketing authorisation will be issued by the European commission in approximately two months.

If approved, topotecan capsules will be the first oral single-agent chemotherapy for the treatment of SCLC after first-line therapy failure.

Eddie Gray, president of Pharmaceuticals Europe at GSK, described the positive opinion as a “significant development” for patients with SCLC across Europe.

“This approval is yet another example of GSK’s continued commitment to researching and developing an industry leading oncology portfolio to address the unmet medical needs of cancer patients around the world,” he confirmed.

As intravenous (IV) topotecan requires five consecutive days of IV therapy every three weeks, GSK has indicated that topotecan capsules will provide patients with another convenient option.

Earlier this month, GSK confirmed that its pneumococcal paediatric vaccine Synflorix had been accepted for review by the EMEA.