Incyte nabs 2nd ever approval ahead of schedule as FDA insists it can still review on time
Almost a full year after Incyte broke off a troubled partnership with Eli Lilly to focus on its own internal engine, one of the drugs from that engine will enter the market.
Pemigatinib, now branded as Pemazyre, obtained FDA approval as a second-line treatment for a rare form of cancer known as cholangiocarcinoma, or bile duct cancer. For Incyte, a biotech that rose to prominence on the strength of a single drug — Jakafi — and a slew of Big Pharma partnerships, the approval marks the first of what they hope will be a series of internal successes and the first sign of a new phase for the company, albeit one that is unlikely to make a huge commercial splash.
The approval came a month before the May 30 PDUFA date and on the same day that a Seattle Genetics drug was cleared four months ahead of its date. FDA officials, having been hounded for over a month with questions about how the Covid-19 crisis would affect the review process for non-Covid drugs, were clear about what the regulatory announcements should signal.
“This approval demonstrates that while we continue to focus our efforts on addressing the COVID-19 pandemic, the FDA remains committed to the important work of reviewing treatments for patients with cancer and other serious conditions,” Richard Pazdur, CDER’s top oncology official, said in a statement.
For all its confident statements and now multiple early approvals, though, the agency acknowledged last week that with staff increasingly focused on reviewing Covid-19 work, “it is possible that we will not be able to sustain our current level of performance indefinitely.”
The Incyte drug had received both breakthrough therapy status and priority review. After ESMO last year, Evaluate pegged peak sales for the drug at $127 million across indications.
Pemgatinib is an inhibitor of FGFR, or fibroblast growth factor, the same kinase targeted by J&J’s bladder cancer drug erdafitinib. In Phase II trial data released last year, Incyte showed the drug led to a progression-free survival of 6.9 months and overall survival of 21.1 months in patients with an FGFR2 mutation. Two other smaller cohorts with different forms of FGFR lived for 6.7 months and 4.0 months, in line with the disease’s standard prognosis. The final duration of response result was 9.1 months.
Incyte hopes to soon show effectiveness in bladder cancer, testing the drug in several Phase II trials for that indication, along with trials for patients with any tumors that have FGFR mutations, irrespective of type. Operating in reverse, J&J is now testing their drug against bile duct cancer, while Incyte pushes to show efficacy as a first-line treatment. Agios also has an experimental bile duct treatment that targets the enzyme IDH1.
If the FDA keeps up its rapid pace, Incyte could soon see another big cancer approval. Novartis’ capmatinib, which the Swiss giant licensed from Incyte back in 2009, has also been granted breakthrough status and priority review for MET-14 breast cancer, with a PDUFA date in August. That deal provided for over $500 million in milestones if Novartis successfully developed the drug, plus 12-14% of sales.
The approval could help shore up investors’ testy faith in Incyte’s ability to expand beyond Jakafi. The company’s stock has swung wildly over the past year, particularly after the withdrawal from the struggling Lilly drug baricitinib and, in January, a large Phase III failure for a graft-versus-host-disease drug. It was up 4.54% from Thursday’s market close, to a flat $100.