Anne Paxton
Take a fatal and nearly untreatable cancer. Invest hundreds of millions of dollars to develop and test a drug that shrinks tumors or improves survival in half of patients with a common mutation. Link diagnosis to a PCR test that you also manufacture. And win an accelerated FDA approval for the test-drug combination.
Altogether, no mean feat. And it’s essentially what Roche accomplished to bring its metastatic melanoma drug Zelboraf (vemurafenib) on the market this year.
By all accounts, Zelboraf should bring new hope to thousands of melanoma patients and perhaps a billion dollars a year in revenue to Roche. “It’s the first ever joint FDA approval of a drug and a DNA-based companion diagnostic, and the beginning of the molecular companion diagnostics era,” says John W. Longshore, PhD, director of molecular pathology for Carolinas Pathology Group, Carolinas Medical Center, Charlotte, NC.
The FDA, in its approach to companion diagnostics, seems to favor single-assay platforms while the field moves toward multiplexed platforms, says Dr. Marc Ladanyi, here at Memorial Sloan-Kettering Cancer Center with colleagues involved in BRAF mutation testing, Maria Arcila, MD (center), and Laetitia Borsu, PhD.
Zelboraf, a kinase inhibitor, has been proven effective only for melanoma patients with the BRAF V600E mutation. But the linkage of Zelboraf to the Roche Cobas 4800 BRAF V600 Mutation Test is creating something of a furor. In its Aug. 17 approval of Zelboraf, the FDA’s Center for Drug Evaluation and Research specified that the drug is indicated “for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test” (emphasis added). So when the FDA Center for Devices and Radiological Health granted pre-market approval for the Cobas test the same day, the Roche assay became the de facto companion diagnostic for Zelboraf.
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