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Incyte's (INCY) Lymphoma Drug Obtains Positive CHMP Opinion

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Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a combination treatment of tafasitamab.

The CHMP has recommended approval of tafasitamab in combination with Bristol Myers’ (BMY - Free Report) Revlimid followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).

The positive opinion from the CHMP is based on data from the phase II L-MIND study.

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibodies. It is marketed under the brand name Monjuvi in the United States where it is indicated in combination with Revlimid for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on the overall response rate.

Upon a tentative approval in the European Union, it will be marketed under the brand name, Minjuvi.

Approval in additional geographies boosts the growth potential of the drug.

Earlier, Incyte announced the outcome of a meeting with the Oncologic Drugs Advisory Committee (ODAC) of the FDA, which reviewed the Biologics License Application (BLA) for oncology candidate, retifanlimab. The candidate is an intravenous PD-1 inhibitor, which is being evaluated as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

The committee voted 13-4 that a regulatory decision on retifanlimab for the treatment of advanced or metastatic SCAC should be deferred until further data from the POD1UM-303 study is available. The ongoing study is a confirmatory study in platinum-naïve advanced SCAC that is currently underway.

Shares of the company have lost 0.6% in the year so far against the industry’s 0.5% growth.

Zacks Investment ResearchImage Source: Zacks Investment Research

The FDA recently extended the review period for Incyte’s New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to Sep 21, 2021.

The FDA also extended the review period for the supplemental New Drug Application (sNDA) for its lead drug, Jakafi (ruxolitinib), by three months. The sNDA is seeking the label expansion of the drug for the treatment of adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).

Incyte’s performance in the first quarter was unimpressive, as Jakafi’s net sales were affected by typical seasonal effects and softer patient demand growth due to the ongoing pandemic. The company has a collaboration agreement with Novartis (NVS - Free Report) for Jakafi.

Incyte currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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