Roche took a step forward in personalized medicine with the approval earlier this month of a new drug and related diagnostic to treat certain forms of metastatic melanoma. Roche’s strategy of developing drugs and related diagnostics shows the potential business and therapeutic value of personalized medicines.

Earlier this month, FDA approved Roch’s Zelboraf (vemurafenib) and companion diagnostic for BRAF mutation-positive metastatic melanoma. Zelboraf is an oral, small-molecule kinase inhibitor indicated for treating patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by the cobas 4800 BRAF V600 Mutation Test, a polymerase chain reaction-based diagnostic test developed by Roche. The B-Raf protein is a key component of the Ras-Raf pathway involved in normal cell growth and survival. Mutations that keep the B-Raf protein in an active state may cause excessive signaling in the pathway, leading to uncontrolled cell growth and survival. These mutations of the B-Raf protein are thought to occur in an estimated half of all melanomas and 8% of solid tumors. Zelboraf is being codeveloped under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group. “The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options,” said Hal Barron, M.D., chief medical officer and head of global product development at Roche, in a company press release.

Among the pharmaceutical majors, Roche is most active in pursuing a strategy of combining molecular diagnostics with targeted drug development. Such an approach has the potential of developing more clinically efficacious drugs, albeit to a smaller, but better defined patient population, which serves the pharmaceutical side of the business, but also Roche’ molecular diagnostics business. In reporting its 2010 results in February 2011, Roche reported that it had 12 new molecular entities in late-stage development, of which six were potential personalized healthcare medicines with planned companion diagnostic tests. The recently approved Zelboraf and related diagnostic test was one of those six treatments.

Analysts are bullish on Zelboraf as a potential blockbuster due to the drug’s potential in addressing an unmet medical need in treating metastatic melanoma. It will be important to watch the financial results for this newly approved drug and related diagnostic as well as the pipeline progression of Roche’s other personalized medicines to see whether the marriage of targeted therapeutics with related molecular diagnostics may indeed represent a new winning paradigm in drug development.