US: FDA approves first NDA under real-time oncology review pilot

30-05-2019

US: FDA approves first NDA under real-time oncology review pilots

(Source: RAPS 2019-05-31)

As the US grapples with whether Novartis’ new gene therapy for spinal muscular atrophy should cost $2.1 million, the US Food and Drug Administration (FDA) on Friday also quietly signaled that another Novartis drug would effectively kick off a new way for cancer drugs to be approved more quickly.

The approval for the breast cancer treatment Piqray (alpelisib) in combination with fulvestrant and alongside a companion diagnostic — came more than three months ahead of its PDUFA deadline and a little more than five months after it was submitted thanks to FDA’s Real-Time Oncology Review (RTOR) pilot and Assessment Aid (AAid) programs.

Up until last Friday, FDA had only approved supplemental new drug applications (sNDAs) and supplemental biologics license applications (sBLAS) under the RTOR pilot. FDA had never even publicly said that it was expanding the RTOR pilot to NDAs until announcing that Piqray’s NDA had been approved.

News of the expanding pilot should be well-received by the biopharma industry, which so far has seen significant time shaved off their application approval timelines thanks to the pilot. For instance, last July, an sNDA for Novartis' breast cancer drug Kisqali (ribociclib) was approved in less than a month after its formal submission. Similarly, an sNDA for Roche’s Kadcyla (trastuzumab emtansine) earlier this month was approved in just over 12 weeks after submission.

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