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AstraZeneca Cancer Drug May Not Get to Market So Fast

Development of competitive drugs adds to the need for better results

AstraZeneca's keenly awaited cancer immunotherapy drug durvalumab may not get to market as quickly as first hoped, but the company says it is more confident than ever in its oncology development pipeline.

According to Reuters, the British drugmaker is running a lung cancer trial known as ATLANTIC that is due to produce results by the end of this year and could, in theory, support a submission seeking accelerated U.S. approval in the first half of 2016. However, this option is now looking less likely since Bristol-Myers Squibb's Opdivo and Merck's Keytruda have already won FDA clearance in lung cancer, reducing the chances of durvalamb gaining rapid approval.

"The landscape has changed because competing products received approval far faster than could have been expected a bit more than a year ago," AstraZeneca Chief Executive Pascal Soriot told reporters in a conference call. Roche also has a competing product, atezolizumab, that it plans to file for approval in lung cancer in the first quarter of 2016.

As a result, the chances of an accelerated FDA approval based on ATLANTIC have decreased because there is a reduced unmet medical need. All four drugs work in a similar way to boost the immune system's ability to detect and fight tumor cells.

Durvalumab is AstraZeneca's most important pipeline product. The company said last year, during its bid defense against a takeover attempt by Pfizer, that the medicine could eventually generate annual sales of $6.5 billion, making it a key component of an overall $45 billion sales forecast for 2023.

While ATLANTIC is looking at durvalumab's use on its own in a subset of late-stage lung cancer patients, Soriot said the drug's real promise lay in combining it with other products to help a much wider range of patients.

"Our long-range forecast for 2023 remains the same. In fact, we now have a little bit more for oncology sales and a little bit less for diabetes in our forecasts," he said. "Getting accelerated approval with our monotherapy was never part of our base plan or our long-range forecasts. We still want to pursue the accelerated approval, but as an upside."

Soriot also said AstraZeneca was considering a marketing partnership deal for its gout drug lesinurad, which was recommended for approval by an FDA advisory panel last month.

Source: Reuters, November 5, 2015.

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