J&J's Drugs Get CHMP Recommendations for Blood Cancer Indications

J&J JNJ announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended granting label expansion to its two key products, Darzalex and Imbruvica, across separate new indications.

CHMP Endorses JNJ’s Darzalex for a New Multiple Myeloma Setting

The EMA committee has issued a positive opinion for expanding Darzalex’s label to treat adults with smoldering multiple myeloma (SMM), who are at high risk of developing multiple myeloma.

If approved, the drug will be the first approved therapy for this patient population. SMM is an asymptomatic, intermediate stage of multiple myeloma marked by the presence of abnormal cells in the bone marrow. The current standard of care for this indication is active monitoring (or, Watch and Wait), with treatment initiated only upon disease progression.

A similar filing is currently under FDA review, also supported by data from the AQUILA study. Last month, an FDA advisory committee also issued a favorable opinion recommending Darzalex’s approval in the SMM indication.

Both the EMA and FDA advisory committee decisions are supported by data from the phase III AQUILA study, which showed that treatment with Darzalex significantly reduced the risk of progression or death compared to active monitoring.

Darzalex is a key driver of sales for J&J. The drug is already approved in the United States and Europe across several settings in multiple myeloma. Darzalex sales rose 20% year over year to $3.24 billion during the first quarter of 2025, driven by continued share gains across all lines of therapy, particularly the front-line setting.

JNJ Stock Performance

Year to date, shares of J&J have risen nearly 4% against the industry‘s 3% decline.

J&J’s Imbruvica Gets CHMP Nod for a New Lymphoma Indication

In a separate press release, the CHMP recommended approving Imbruvica’s label to treat adults with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant (ASCT). J&J seeks approval to use this drug in combination with chemotherapy and other drugs like rituximab and prednisolone.

If approved, Imbruvica could be the first BTK inhibitor for this setting. MCL is a rare, aggressive form of non-Hodgkin lymphoma. The current standard of care for frontline MCL is a chemotherapy regimen including ASCT, often with high toxicity and resource use. Per J&J, adding fixed-duration Imbruvica could offer long remissions without transplant burden.

The CHMP decision is based on data from the late-stage TRIANGLE study, which showed that treatment with Imbruvica plus chemotherapy significantly improved overall survival without the burden of transplant.

J&J markets Imbruvica in partnership with AbbVie ABBV. While both JNJ and ABBV share commercial responsibilities in the United States, J&J is responsible for marketing the drug outside the country. AbbVie shares international profits earned from Imbruvica with J&J. The drug is already approved in the United States and Europe for other indications, including previously treated MCL, chronic lymphocytic leukaemia and lymphoplasmacytic lymphoma.

J&J’s Zacks Rank

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

Johnson & Johnson Price

 

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Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Immunocore IMCR and Agenus AGEN. While IMCR sports a Zacks Rank #1 (Strong Buy) at present, AGEN carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, loss per share estimates for Immunocore’s 2025 have improved from $1.50 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained 6% year to date.

Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.

In the past 60 days, Agenus’ bottom-line estimates for 2025 have significantly improved from a loss of $3.46 per share to earnings of $1.56. During the same timeframe, estimates for 2026 loss per share have narrowed from $3.91 to $1.99. AGEN stock has soared 74% so far this year.

Agenus’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 22.71%.

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