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J&J Wins CHMP Nod for Expanded Use of Multiple Myeloma Drug Tecvayli
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Key Takeaways
JNJ won CHMP backing for Tecvayli plus Darzalex SC in adults with RRMM after at least one prior therapy.
Tecvayli plus Darzalex SC cut the risk of disease progression or death by 83.4% versus standard care.
JNJ reported 83.3% overall survival at three years for the combination in the MajesTEC-3 study.
Johnson & Johnson (JNJ - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the expanded use of Tecvayli (teclistamab) in multiple myeloma.
The CHMP has now recommended approval of Tecvayli in combination with the Darzalex subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy.
The latest CHMP nod was based on data from the phase III MajesTEC-3 study, which evaluated the safety and efficacy of Tecvayli in combination with Darzalex SC versus the investigator’s choice of Darzalex SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received one to three prior lines of therapy.
Data from the same showed that, at nearly three years of follow-up, treatment with the combo of Tecvayli plus Darzalex SC led to an 83.4% reduction in the risk of disease progression or death versus the current standard of care. The combo of Tecvayli plus Darzalex SC demonstrated 83.3% overall survival versus 65% for the standard of care at three years.
The safety profile of Tecvayli plus Darzalex SC was similar to the well-known profiles of the individual therapies.
JNJ’s Price Performance
Year to date, shares of J&J have rallied 24.4% compared with the industry’s growth of 13.1%.
Image Source: Zacks Investment Research
JNJ’s Ongoing Activities With Tecvayli
Tecvayli is currently approved in Europe for treating patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have shown disease progression on the last therapy.
In March 2026, JNJ submitted a type II variation application to the EMA seeking approval of Tecvayli as a monotherapy for the treatment of adult patients with RRMM who have received at least one prior therapy.
Tecvayli is approved in the United States for the treatment of RRMM, both as monotherapy in heavily pretreated patients and in combination therapy in earlier treatment lines. The FDA granted accelerated approval in October 2022 for adults with RRMM who had received at least four prior lines of therapy.
The FDA approved Tecvayli in combination with Darzalex Faspro for the treatment of adults with RRMM who have received at least one prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor, in March 2026.
Tecvayli is one of J&J’s new cancer drugs that is making meaningful contributions to the company’s top line. The drug recorded sales worth $202 million in the first quarter of 2026, up 33.5% year over year, driven by launch uptake, share gains from continued expansion into the community setting and the launch of Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have surged 43.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 126.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
Image: Bigstock
J&J Wins CHMP Nod for Expanded Use of Multiple Myeloma Drug Tecvayli
Key Takeaways
Johnson & Johnson (JNJ - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the expanded use of Tecvayli (teclistamab) in multiple myeloma.
The CHMP has now recommended approval of Tecvayli in combination with the Darzalex subcutaneous (daratumumab SC) formulation for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy.
The latest CHMP nod was based on data from the phase III MajesTEC-3 study, which evaluated the safety and efficacy of Tecvayli in combination with Darzalex SC versus the investigator’s choice of Darzalex SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received one to three prior lines of therapy.
Data from the same showed that, at nearly three years of follow-up, treatment with the combo of Tecvayli plus Darzalex SC led to an 83.4% reduction in the risk of disease progression or death versus the current standard of care. The combo of Tecvayli plus Darzalex SC demonstrated 83.3% overall survival versus 65% for the standard of care at three years.
The safety profile of Tecvayli plus Darzalex SC was similar to the well-known profiles of the individual therapies.
JNJ’s Price Performance
Year to date, shares of J&J have rallied 24.4% compared with the industry’s growth of 13.1%.
Image Source: Zacks Investment Research
JNJ’s Ongoing Activities With Tecvayli
Tecvayli is currently approved in Europe for treating patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have shown disease progression on the last therapy.
In March 2026, JNJ submitted a type II variation application to the EMA seeking approval of Tecvayli as a monotherapy for the treatment of adult patients with RRMM who have received at least one prior therapy.
Tecvayli is approved in the United States for the treatment of RRMM, both as monotherapy in heavily pretreated patients and in combination therapy in earlier treatment lines. The FDA granted accelerated approval in October 2022 for adults with RRMM who had received at least four prior lines of therapy.
The FDA approved Tecvayli in combination with Darzalex Faspro for the treatment of adults with RRMM who have received at least one prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor, in March 2026.
Tecvayli is one of J&J’s new cancer drugs that is making meaningful contributions to the company’s top line. The drug recorded sales worth $202 million in the first quarter of 2026, up 33.5% year over year, driven by launch uptake, share gains from continued expansion into the community setting and the launch of Tecvayli plus Darzalex Faspro for relapsed/refractory multiple myeloma.
JNJ’s Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Kiniksa Pharmaceuticals (KNSA - Free Report) , Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 EPS have increased from $1.09 to $1.24. Over the same period, EPS estimates for 2027 have risen from $1.54 to $1.70. KNSA shares have surged 43.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed in the remaining two quarters, with the average surprise being 1.53%.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 11% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 126.7% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.