Chugai and Roche get U.S. FDA priority review on alectinib

Japan's Chugai Pharmaceutical and Switzerland's Roche's ($RHBBY) and its Genentech unit received U.S. FDA acceptance for a new drug application of alectinib for ALK-positive advanced non-small cell lung cancer in patients for whom crizotinib is no longer an option.

The drug was granted FDA breakthrough therapy designation on lung cancer in 2013.

Chugai is majority-owned by Roche, and talk last year was that the Swiss company wanted to spend up to $10 billion to buy the remaining 40%. But in January, the company said there is no hurry in concluding a deal and wondered if it was even necessary at all.

The candidate has shown steady clinical progress, with Roche discussing alectinib in non-small cell lung cancer in May at the American Society for Clinical Oncology meeting in Chicago.

In the July second-quarter earnings release, Roche said in Japan, Alecensa (alectinib) was approved for the treatment of ALK-positive non-small cell lung cancer based on a Japanese trial. Alecensa has been available in Japan since September 2014, with rights overseas, including Europe and the U.S., outlicensed to Roche with related clinical work ongoing.

Roche COO Daniel O'Day

Dan O'Day, Roche chief operating officer, also highlighted Japan on the second-quarter earnings call, noting "the entire portfolio, oncology, immunology really growing nicely in all indications at plus 7%."

Alectinib was developed by Chugai, the company said in a release, and matches with the "Personalized Healthcare Strategy promoted by Chugai and Roche."

"It has been reported that 2% to 5% of patients with NSCLC express a chromosomal rearrangement which leads to fusion of the ALK gene with another gene," Chugai said in the release.

"ALK kinase signaling is constantly active in cells with such fusion genes, resulting in uncontrolled growth of tumor cells and transforming the cells into tumor cells. Alectinib exerts its anti-tumor effect by selectively inhibiting ALK kinase activity to inhibit tumor cell proliferation and induce cell death. In addition, alectinib is not recognized by the transporter proteins in the blood brain barrier that actively pump molecules out of the brain. Alectinib is active in the central nervous system and has proven activity against brain metastases."

Sandra Horning, Roche's chief medical officer and head of global product development

Earlier this week, the U.S. FDA designated Chugai's ACE910 as a breakthrough therapy for hemophilia A in a first for the therapy focus. The candidate was initially developed by Chugai and was opted into by Roche.

Roche also said on Sept. 9 that it would present data from 138 abstracts at this year's European Cancer Congress (ECC) from Sept. 25 to 29.

"With our targeted medicines, cancer immunotherapies and the combination potential in our portfolio, we are committed to setting new standards for treating people with cancer," said Sandra Horning, Roche's chief medical officer and head of Global Product.

In addition to data for alectinib, results will be presented for atezolizumab and cobimetinib.

- here's the release

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