Novartis fuels drive for fast OK of LDK378 with new lung cancer data

Novartis has taken another step forward in its quest to win a fast approval for its lung cancer drug LDK378. The pharma giant says the ALK inhibitor demonstrated clear signs of activity in a majority of the non-small cell lung cancer patients enrolled in an early study, including a group already treated by the ALK inhibitor Xalkori (crizotinib).

In a group of 114 ALK-positive lung cancer patients taking a daily dose ranging up from 400 mg, investigators tracked a 58% overall response that included complete and partial responses and a median progression-free survival rate of 7 months. Under the old normal, those averages would represent a solid positive for Novartis ($NVS) as it pursued new Phase II and eventually Phase III data that would likely take some time to accomplish.

But this is the new normal, in which an aggressive development team at Novartis is testing the FDA's appetite for significantly shortening the development path for key drugs it dubs "breakthrough" therapies. FDA cancer drug czar Richard Pazdur--an advocate of targeted cancer therapies like this--made a high-profile commitment to the BTD program at ASCO last summer. And LDK378 (ceritinib) is one of the three breakthrough drugs from Novartis recognized by the FDA, a group that includes BYM338 and the troubled program for serelaxin. Novartis filed for an approval of LDK378 at the end of January, well ahead of Phase III results from two trials currently recruiting patients. Two Phase II trials are fully enrolled and in progress.

Non-small cell lung cancer is the most common type of lung cancer and patients who test positive for the ALK gene "rearrangement" spurring cancer cell growth account for up to 7.5% of the patient population.

Alessandro Riva, president, global head of oncology development and medical affairs at Novartis

Novartis's regulatory offensive has major implications for Ariad ($ARIA), which has a rival program underway for AP26113. But Ariad, which has had its hands full getting Iclusig back on the market, failed in its attempt to wrestle a breakthrough designation from the FDA, putting it behind the leviathan pharma company in the race to the market.

"These pivotal data published in NEJM served as the basis for our first regulatory filing for LDK378," said Alessandro Riva, the global head of oncology development and medical affairs at Novartis. "We are pleased that the FDA has accepted our application, and we look forward to working with the FDA and health authorities worldwide to bring this important treatment option to patients in need as swiftly as possible."   

- here's the release

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