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Thursday, May 1, 2014


By John Carroll Comment | Forward | Twitter | Facebook | LinkedIn

After a quick march through the clinic, Novartis ($NVS) has won early FDA approval for the new "breakthrough" lung cancer drug ceritinib (or LDK378), which will now be launched as Zykadia.
FDA Oncology Chief Richard Pazdur
The agency approved the drug for ALK-positive non-small cell lung cancer among patients already treated with Xalkori (crizotinib).
The FDA's approval of Zykadia marks a new chapter in cancer drug development. FDA cancer drug czar Richard Pazdur has promised to accelerate any new cancer therapies that win the agency's "breakthrough" drug status. And he's delivered now for Novartis, which has spotlighted this drug as one of their most important development initiatives.
Investigators for the pharma giant recently reported that in a group of 114 ALK-positive lung cancer patients taking a daily dose ranging up from 400 mg, investigators tracked a 58% overall response that included complete and partial responses and a median progression-free survival rate of 7 months. Under the old normal, those averages would represent a solid positive for Novartis as it pursued new Phase II and eventually Phase III data that would likely take some time to accomplish. Today, with the backing of top agency officials, it's a ticket to an early entry in the market, in this case even beating the PDUFA date by four months.
An early approval like this could also encourage other developers to shoot for accelerated approval in cancer. Pfizer ($PFE), which is now focused on a megamerger with AstraZeneca ($AZN), has been studying its chances with the breast cancer drug palbociclib. And Novartis has also been hinting recently that it may take the plunge on Phase II data for LDE225, an oral therapy for basal cell carcinoma.
Novartis didn't miss the chance of celebrating its effectiveness in the cancer drug field, an arena that is slated to soon swell as it swaps out its vaccines business for GlaxoSmithKline's ($GSK) oncology drugs--along with rights to its AKT inhibitor afuresertib--and options on experimental drugs.
Alessandro Riva, president, global head of oncology development and medical affairs at Novartis
"The approval of Zykadia less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly focused approach to drug development and strong collaboration," said Dr. Alessandro Riva, president ad interim, Novartis Oncology and global head, oncology development and medical affairs.
"Today's approval illustrates how a greater understanding of the underlying molecular pathways of a disease can lead to the development of specific therapies aimed at these pathways," said Pazdur in a statement. "It also demonstrates the FDA's commitment to working cooperatively with companies to expedite a drug's development, review and approval, reflecting the promise of the breakthrough therapy designation program."

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