JNJ Applies for Broader Approval of Multiple Myeloma Medication Tecvayli in Europe

Johnson & Johnson Pursues Broader Approval for Tecvayli in Europe

Johnson & Johnson (JNJ) has submitted a type II variation application to the European Medicines Agency (EMA) to expand the use of Tecvayli (teclistamab). The company is seeking authorization for Tecvayli as a standalone treatment for adults with relapsed or refractory multiple myeloma (RRMM) who have undergone at least one previous therapy.

Currently, Tecvayli is approved in Europe for patients with RRMM who have already received at least three different treatments, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, and whose disease has progressed despite these therapies.

In the past year, JNJ’s stock has climbed 49.6%, outpacing the industry average growth of 14.3%.

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Phase III MajesTEC-9 Study Supports EMA Application

The request to expand Tecvayli’s indication is based on results from the ongoing phase III MajesTEC-9 trial. This study compared the effectiveness and safety of Tecvayli to standard treatment regimens, such as pomalidomide, bortezomib, and dexamethasone (PVd), or carfilzomib and dexamethasone (Kd), in patients with RRMM.

Findings revealed that teclistamab provided significant benefits over standard therapies, including improved progression-free and overall survival, even when used as a second-line treatment. The drug lowered the risk of disease progression or death by 71% and reduced the risk of death by 40% in a group largely resistant to anti-CD38 monoclonal antibodies and lenalidomide.

Tecvayli as a single agent demonstrated a safety profile consistent with earlier studies, with no unexpected safety concerns emerging.

Additional Details on Tecvayli

In the United States, Tecvayli is also approved for RRMM, both as a monotherapy for heavily pretreated patients and as part of combination regimens for earlier lines of therapy.

The FDA granted accelerated approval in October 2022 for adults with RRMM who had received at least four previous treatments.

More recently, the FDA approved Tecvayli in combination with Darzalex Faspro for adults with RRMM who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor.

In January, JNJ also submitted a type II variation application to the EMA to expand Tecvayli’s use in combination with the subcutaneous formulation of Darzalex (daratumumab SC) for adults with RRMM who have received at least one prior therapy. This submission is supported by data from the phase III MajesTEC-3 trial.

In 2025, Tecvayli generated $670 million in global sales, marking a 22% increase from the previous year, fueled by broader adoption in community settings.

JNJ’s Stock Rating and Other Biotech Leaders

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

Leading biotech stocks include Catalyst Pharmaceuticals (CPRX), which has a Zacks Rank #1 (Strong Buy), as well as ANI Pharmaceuticals (ANIP) and Castle Biosciences (CSTL), both rated Zacks Rank #2 (Buy). See the full list of Zacks #1 Rank stocks here.

• Over the last 60 days, Catalyst Pharmaceuticals’ projected 2026 earnings per share increased from $2.55 to $2.82. CPRX shares have risen 16.9% in the past year.
• Catalyst Pharmaceuticals has surpassed earnings estimates in each of the last four quarters, with an average surprise of 35.19%.
• ANI Pharmaceuticals’ 2026 earnings per share estimates have grown from $8.28 to $9.00 over the past 60 days, and its stock has gained 20% over the past year.
• ANI Pharmaceuticals also exceeded earnings expectations in each of the last four quarters, averaging a 22.21% surprise.
• Castle Biosciences’ projected 2026 loss per share narrowed from $1.11 to $1.06 in the past 60 days. CSTL shares have advanced 35.5% over the past year.
• Castle Biosciences beat earnings estimates in three of the last four quarters, with an average surprise of 34.69%.

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• Johnson & Johnson (JNJ): Free Stock Analysis Report
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This article was originally published by Zacks Investment Research.

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