Incyte Gets FDA Nod for the Expanded Use of Monjuvi in Lymphoma

Incyte INCY announced that the FDA has approved its humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, Monjuvi (tafasitamab-cxix), for a new cancer indication.

The U.S. regulatory body approved Monjuvi in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL), a type of slow-growing blood cancer.

The latest FDA nod marks the second approved indication for Monjuvi in the United States. Additionally, Monjuvi, in combination with Rituxan and Revlimid, has now become the first CD19- and CD20-targeted immunotherapy combination approved by the FDA for treating adult patients with FL.

Monjuvi was granted accelerated approval by the FDA, in combination with Revlimid, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant in 2020.

Year to date, shares of Incyte have lost 1.1% compared with the industry’s decline of 4.8%.

More on the Latest FDA Nod for INCY's Monjuvi

The FDA nod for the expanded use of Monjuvi was based on data from the pivotal phase III inMIND study, which evaluated the safety and efficacy of Monjuvi in combination with Rituxan and Revlimid in adult patients with relapsed or refractory FL.

Data from the inMIND study showed that treatment with the combo of Monjuvi plus Rituxan and Revlimid led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment — the primary endpoint of the study.

Also, patients who were treated with the combo of Monjuvi plus Rituxan and Revlimid experienced a median PFS of 22.4 months (by investigator assessment) versus 13.9 months in the control arm.

Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG in February 2024. Tafasitamab is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets.

Minjuvi/Monjuvi’s revenues totaled $29.6 million in the first quarter of 2025, increasing 24% year over year. The continued label expansion of the drug is likely to boost sales further in 2025.

Tafasitamab is also being studied as a therapeutic option in first-line DLBCL.

INCY's Zacks Rank & Stocks to Consider

Incyte currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Exelixis EXEL, Amarin Corporation AMRN and Puma Biotechnology PBYI, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have increased 22.4%.

EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.

In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.00 to $2.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $1.78. Year to date, shares of AMRN have surged 37.4%.

AMRN’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 29.11%.

In the past 60 days, estimates for Puma Biotechnology’s earnings per share have increased from 60 cents to 65 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 46 cents to 51 cents. Year to date, shares of PBYI have risen 11.5%.

PBYI’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 171.43%.

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