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Bristol Myers Squibb (BMY - Free Report) announced that the European Medicines Agency (“EMA”) has validated its type II variation application to expand the indication for CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).
The application seeks to expand Breyanzi’s label to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
Validation of the application confirms that the submission is complete and facilitates the initiation of review under the EMA’s centralized evaluation procedure.
Please note that Breyanzi is currently approved in the European Union for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and FL grade 3B.
The application is supported by data from the mid-stage TRANSCEND FL study, the largest study to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. According to data, Breyanzi showed deep and durable responses and a consistent and well-established safety profile.
FL accounts for 20-30% of all NHL cases.
Breyanzi also obtained approval in Japan for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy.
Label expansion of Breyanzi should expand its potential target population.
Breyanzi has witnessed a strong uptake since approval. Sales in the second quarter jumped 53% to $153 million.
Breyanzi is also approved in the United States for the treatment of relapsed or refractory large B-cell lymphoma after at least one prior line of therapy. It was granted accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy and relapsed or refractory FL in the third-line plus setting. Breyanzi is also approved for the treatment of relapsed or refractory mantle cell lymphoma in the third-line plus setting.
The company’s shares have lost 3.9% year to date against the industry's gain of 0.2%.
Image Source: Zacks Investment Research
BMY has another CAR T cell therapy Abecma in its portfolio that is approved in the United States for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
In April, the FDA approved a label expansion of Abecma for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
It is to be noted that Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio (TSVT - Free Report) . Outside the United States, BMY assumes the sole responsibility for Abecma’s manufacturing and commercialization.
However, Abecma’s performance has been hit by competitive pressure in the multiple myeloma space.
The CAR T cell therapy space is dominated by top players like Novartis, Gilead Sciences and Johnson & Johnson, among others.
Last month, Bristol-Myers reported better-than-expected second-quarter results as growth in Eliquis, Opdivo and Reblozyl drove sales and earnings.
BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis.
Krystal Biotech’s earnings per share (EPS) estimate for 2024 has decreased to $2.09 from $2.38 in the past 30 days. Shares of KRYS have surged 51.1% year to date.
BMRN’s EPS estimate for 2024 has increased to $3.18 from $2.78 in the past 30 days, and the same for 2025 has increased 29 cents to $3.95 in the past 30 days.
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Bristol Myers' (BMY) Breyanzi Label Expansion Application Validated
Bristol Myers Squibb (BMY - Free Report) announced that the European Medicines Agency (“EMA”) has validated its type II variation application to expand the indication for CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).
The application seeks to expand Breyanzi’s label to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy.
Validation of the application confirms that the submission is complete and facilitates the initiation of review under the EMA’s centralized evaluation procedure.
Please note that Breyanzi is currently approved in the European Union for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and FL grade 3B.
The application is supported by data from the mid-stage TRANSCEND FL study, the largest study to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including FL. According to data, Breyanzi showed deep and durable responses and a consistent and well-established safety profile.
FL accounts for 20-30% of all NHL cases.
Breyanzi also obtained approval in Japan for the treatment of relapsed or refractory FL after one prior line of systemic therapy in patients with high-risk FL and after two or more lines of systemic therapy.
Label expansion of Breyanzi should expand its potential target population.
Breyanzi has witnessed a strong uptake since approval. Sales in the second quarter jumped 53% to $153 million.
Breyanzi is also approved in the United States for the treatment of relapsed or refractory large B-cell lymphoma after at least one prior line of therapy. It was granted accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior lines of therapy and relapsed or refractory FL in the third-line plus setting. Breyanzi is also approved for the treatment of relapsed or refractory mantle cell lymphoma in the third-line plus setting.
The company’s shares have lost 3.9% year to date against the industry's gain of 0.2%.
Image Source: Zacks Investment Research
BMY has another CAR T cell therapy Abecma in its portfolio that is approved in the United States for adult patients with triple-class exposed relapsed or refractory multiple myeloma after four or more prior lines of therapy.
In April, the FDA approved a label expansion of Abecma for treating adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
It is to be noted that Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio (TSVT - Free Report) . Outside the United States, BMY assumes the sole responsibility for Abecma’s manufacturing and commercialization.
However, Abecma’s performance has been hit by competitive pressure in the multiple myeloma space.
The CAR T cell therapy space is dominated by top players like Novartis, Gilead Sciences and Johnson & Johnson, among others.
Last month, Bristol-Myers reported better-than-expected second-quarter results as growth in Eliquis, Opdivo and Reblozyl drove sales and earnings.
BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis.
Zacks Rank & Other Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Krystal Biotech (KRYS - Free Report) and BioMarin (BMRN - Free Report) . While KRYS sports a Zacks Rank #1 (Strong Buy), BMRN carries the same rank as BMY. You can see the complete list of today’s Zacks #1 Rank stocks here.
Krystal Biotech’s earnings per share (EPS) estimate for 2024 has decreased to $2.09 from $2.38 in the past 30 days. Shares of KRYS have surged 51.1% year to date.
BMRN’s EPS estimate for 2024 has increased to $3.18 from $2.78 in the past 30 days, and the same for 2025 has increased 29 cents to $3.95 in the past 30 days.