Europe pushes back verdict on Bristol immune system cancer drug

(Adds comment from Bristol-Myers, paragraph 4)

LONDON, March 27 (Reuters) - European regulators have postponed a decision on whether to recommend approval of a closely watched Bristol-Myers Squibb drug that helps the immune system fight cancer, officials said on Friday.

Nivolumab, which is already approved in the United States under the brand name Opdivo for melanoma and lung cancer, was on the agenda at a monthly meeting of European Medicines Agency (EMA) experts, but no verdict was reached.

The committee is considering whether to recommend the antibody medicine for treating advanced melanoma in adults.

A Bristol-Myers spokeswoman said the delay was due to the fact that the drugmaker had submitted additional data over the course of the review period. She declined to give details.

Such delays are not uncommon when questions arise and officials feel they need more information to evaluate a medicine. Nivolumab, which is already being reviewed on an accelerated basis at the EMA, could be considered again either in April or at a later date, an agency spokeswoman said.

The EMA did hand down positive recommendations on a number of other products, including a nine-strain version of Merck (LSE: 0O14.L - news) 's cervical cancer vaccine Gardasil 9.

Bristol's nivolumab belongs to a highly promising new class of medicines called PD-1 inhibitors that block a mechanism tumours use to hide from the immune system. It is expected to be one of the most commercially successful new drugs to reach major markets this year.

It competes with Merck (Swiss: MER.SW - news) & Co's Keytruda, which is also on the market in the United States but not in Europe.

Although Keytruda is still be waiting for regulatory approval in Europe, some patients in Britain will soon receive it through a new early-access scheme, under which highly promising new drugs are made available ahead of formal licensing. (Reporting by Ben Hirschler; Editing by William Hardy)