Archive for August, 2016

MSD’s Keytruda approved in EU for lung cancer

Posted on August 3rd, 2016 by Valorem Life Sciences

Treatment options in Europe for patients with certain forms of lung cancer are being expanded with the approval of MSD’s immunotherapy Keytruda.

The European Commission has cleared the drug’s use to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen.

The decision came after data from two studies – KEYNOTE-010, which assessed overall survival (OS) and KEYNOTE-001, which looked at overall response rates (ORR) – showed significant improvements in patients taking Keytruda (pembrolizumab).

In KEYNOTE-010, both doses of MSD’s drug significantly improved OS compared with docetaxel; Keytruda resulted in a 29 percent improvement for the 2 mg/kg dose and a 39 percent improvement for the 10 mg/kg dose. Median OS for was 10.4 months and 12.7 months, respectively, compared to 8.5 months for docetaxel.

Among patients with higher levels of PD-L1 expression, OS was superior for both Keytruda doses, improving 46 percent for the lower dose and 50 percent for the higher one compared to docetaxel. Median OS was 14.9 months, 17.3 months and 8.2 months, respectively.

“We are thrilled that the European Union will now have a new treatment option for certain patients with advanced non-small cell lung cancer who have not responded to chemotherapy,” said Stefania Vallone, president, Lung Cancer Europe.

“Lung cancer represents the leading cause of cancer death worldwide, and this milestone underscores the importance of innovation and commitment to developing new treatments that can have a positive impact for patients living with this disease.”

Keytruda, a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands to activate the immune system, is already on the market in Europe to treat advanced melanoma.

Source: Pharma Times