3 NEW DRUGS NEAR APPROVAL BY EMA 

The European panel responsible for assessing data on drugs and treatments that are ultimately approved or rejected by the European Commission endorsed 3 cancer medicines this week.

At its June meeting, the Committee for Medicinal Products for Human Use (CHMP) gave positive opinions on dabrafenib (Tafinlar, GlaxoSmithKline), sipuleucel-T (Provenge, Dendreon), and regorafenib (Stivarga, Bayer).

Dabrafenib is a targeted therapy for the treatment of unresectable or metastatic melanoma in carriers of the BRAFV600 mutation. It will be the second BRAF inhibitor in the European Union; vemurafenib, a first-in-class protein kinase inhibitor that inhibits the BRAF serine/threonine kinase with a genetic mutation at position 600 (BRAF V600E), was approved in Europe in February 2012. A third BRAF inhibitor, trametinib, is currently under evaluation by the CHMP.

Dabrafenib, which is an oral therapy, has been shown to delay the progression of metastatic melanoma and to improve the response rate better than dacarbazine, a single-agent chemotherapy commonly used in the treatment of metastatic melanoma. Dabrafenib is indicated as monotherapy.

Mutations of the BRAF protein kinase have been identified in about half of patients with metastatic melanoma, and the BRAF V600E mutation is found in about 80% to 90% of these patients.

Sipuleucel-T is a cell-based therapy recommended for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. Sipuleucel-T has been shown in clinical trials to improve overall survival by 4.1 months, compared with placebo. As an immunotherapy, sipuleucel-T is considered to be less toxic than the therapies currently available for this indication, according to press materials from the CHMP. Therefore, the review panel concluded that the benefits of sipuleucel-T outweigh its risks, and recommended its marketing authorization. The US Food and Drug Administration (FDA) approved sipuleucel-T in April 2010.

Regorafenib is an oral therapy for the treatment of metastatic colorectal cancer. It is a novel multikinase inhibitor that blocks multiple enzymes that promote cancer growth. In the drug's pivotal randomized phase 3 trial in metastatic colorectal cancer, known as CORRECT, median overall survival was 6.4 months with regorafenib and 5.0 months with placebo. The FDA approved regorafenib for the treatment of metastatic colorectal cancer in September 2012.