Xalkori And Zelboraf: The Highs And Lows Of Commercializing Targeted Cancer Drugs

WhenRoche’s Zelboraf (vemurafenib) and Pfizer Inc.’s Xalkori (crizotinib) were cleared by FDA, they were heralded as the first in a wave of next-generation personalized cancer drugs, therapies approved in tandem with a companion diagnostic to identify the patients most likely to respond to treatment. But while they are clear medical and regulatory wins, the experience from the first year of marketing suggests that commercial success may be harder to achieve.

Zelboraf and Xalkori are both great success stories. They sailed through development and regulatory approval (Zelboraf was approved by FDA in 3.6 months and Xalkori in less than five); have been welcomed on the market by patients, physicians and even payers, despite their high cost; and represent a significant advance in the treatment of two of the deadliest cancers. Both drugs offer a survival advantage over the former standard of care – but only in a subset of patients whose tumors present with certain gene mutations. Zelboraf helps metastatic melanoma patients with tumors expressing the V600 BRAF mutation and Xalkori helps non-small cell lung cancer patients with tumors expressing the EML4-ALK mutation