* U.S. regulators allow clinical trial to resume
* Trial evaluates Avastin with chemotherapy in breast cancer
* Also reports positive mid-stage Herceptin data
* Stock in line with European sector
* Roche shares near flat
(Adds details on Avastin, Herceptin results, stock)
By Catherine Bosley and Sam Cage
ZURICH, Dec 14 The U.S. Food and Drug
Administration is allowing Roche Holding AG ROG.VX to resume
enrolment to a late-stage trial of Avastin in early-stage
HER2-negative breast cancer, the Swiss drugmaker said on Monday.
Enrolment in the trial had been temporarily suspended on
Sept. 25, because six cases of clinical congestive heart failure
(CHF) were reported during a pre-planned cardio-toxicity analysis
of the first 200 patients.
Roche, the world's largest maker of cancer drugs, said the
study's data safety monitoring board had concluded that the
risk-benefit assessment of Avastin in combination with
anthracycline, cyclophosphamide and paclitaxel chemotherapy in
this trial remained unchanged.
Avastin, which works by starving tumours of blood supply and
is made by Roche's recently acquired Genentech unit, is also
used to treat lung and colon cancers, and had annual global
sales of 5.2 billion Swiss francs ($5.1 billion) in 2008.
The Phase III trial (E5103) began enrolment in November 2007
and 3,487 of the planned 4,950 patients have been enrolled to
date, Roche said.
Roche also reported positive results from a mid-stage trial
of another of its drugs, trastuzumab-DM1, against advanced HER2
positive breast cancer. The medicine is a combination of Roche's
Herceptin and a cancer cell killing agaent from U.S. group
The data are encouraging but the treatment is sufficiently
far away from market that it revenues are not yet included in
models for Roche, analysts said.
Roche stock was down 0.5 percent by 1044 GMT at 167.70 Swiss
francs, while the DJ Stoxx European healthcare index .SXDP was
down 0.3 percent.
(Editing by David Holmes and Mike Nesbit)
($1=1.030 Swiss Franc)