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Incyte's Application for Pemigatinib Gets EMA's Validation

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Incyte Corporation (INCY - Free Report) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for its investigational FGFR inhibitor pemigatinib to treat adult patients with locally advanced/metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy. Cholangiocarcinoma is also known as bile-duct cancer.

The marketing application in Europe was based on data from the phase II FIGHT-202 study, which evaluated the safety and efficacy of pemigatinib in the given patient population.

We remind investors that in November 2019, the FDA accepted and granted a priority review to the new drug application (NDA) for pemigatinib as a second-line treatment of locally advanced or metastatic cholangiocarcinoma. A decision from the regulatory body is expected on May 30, 2020.

The NDA too was based on data from the phase II FIGHT-202 study. Results from the same showed that treatment with pemigatinib monotherapy led to an overall response rate (ORR) of 36% (primary endpoint) and a median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. No serious side effects were reported.

Shares of Incyte have increased 4.7% in the past year against its industry’s decrease of 2.4%.

Cholangiocarcinoma is often diagnosed at an advanced stage when the prognosis is poor. Hence a potential approval of pemigatinib both in the United States and Europe will provide a new treatment option for patients suffering this dreadful disease and drive growth for Incyte in the future.

Notably, in June 2019, Incyte initiated a phase III study on pemigatinib for the first-line treatment of patients with cholangiocarcinoma and FGFR2 fusions or rearrangements. The candidate is also being evaluated in a phase II study for bladder cancer.

We would like to remind investors that Agios Pharmaceuticals (AGIO - Free Report) is also evaluating its leukemia drug Tibsovo in the phase III ClarIDHy study for addressing previously treated patients with IDH1 mutant cholangiocarcinoma. The company plans to file a supplemental new drug application (sNDA) to the FDA for Tibsovo to treat cholangiocarcinoma. Currently, there are no treatment options available to treat this cancer.

Zacks Rank & Stocks to Consider

Incyte currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the biotech sector include Emergent Biosolutions Inc. (EBS - Free Report) and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have moved 5.6% north for 2020 over the past 60 days.

Alexion’s earnings estimates have been revised 0.4% upward for 2020 over the past 60 days.

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