Hal Barron, head of global product development, said: “Today’s approval is
important news for people with BRAF mutation-positive metastatic melanoma as
Zelboraf significantly improves patient survival and exemplifies the benefits
that Roche’s personalised approach to medicine can provide for patients, physicians
and society.” Zelboraf is being co-developed under a 2006 licence and collaboration
agreement between Roche and Plexxikon, a member of the Daiichi Sankyo
Group.
Analysts’ forecasts see the drug making around $750 million in peak annual
sales.
The drug targets the BRAF protein, which is a key component of the RAS-RAF
pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state may cause excessive
signalling in the pathway, leading to uncontrolled cell growth and survival.
These mutations are thought to occur in around half of all melanomas, and
8% of solid tumours.
The approval is based on a pivotal Phase III trial that showed Zelboraf
improved progression-free survival by about 4 months (5.3 months for vemurafenib
compared to 1.6 months for chemotherapy agent dacarbazine).
It also increased overall survival by about 3 months (13.2 months for
Zelboraf compared to 9.9 months for dacarbazine), in patients who tested
positive for BRAF V600 mutations.
It will now compete with Bristol-Myers Squibb’s immunotherapy treatment Yervoy
(ipilimumab), which is also licensed in Europe to treat advanced melanoma. But Yervoy’s high cost of £80,000 per year, per patient, has seen it fall
foul of the UK cost watchdog NICE, which has said in draft guidance that it
will not recommend the drug for funding on the NHS.
NICE will start its appraisal on Zelboraf in the coming weeks, and is
scheduled to make its final decision on the drug in October.
But once the drug is launched in England it will eligible for funding via
the £200 million Cancer Drugs Fund, which pays for new cancer drugs that are
going through the NICE appraisal system, or that have been rejected by the
watchdog.