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Bristol Myers (BMY) Gets FDA Nod for Breyanzi's Label Expansion
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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has granted accelerated approval to chimeric antigen receptor (CAR) T cell therapy, Breyanzi (lisocabtagene maraleucel), for one more indication.
The approval was granted for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. The accelerated approval was based on the response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with median duration of CR not reached, along with an established safety profile.
CLL and SLL are among the most common types of B-cell lymphoma, and patients often experience relapse or become refractory following early-line treatment with targeted therapies, including BTK- and BCL-2 inhibitors.
Hence, the approval of Breyanzi in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL2i shifts the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance to a one-time personalized T-cell-based approach that has the potential to offer patients complete and lasting remission.
Breyanzi is a CD19-directed genetically modified autologous T cell immunotherapy that is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
The therapy is approved in the United States, Japan and Europe for the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL), and in Japan, Europe, Switzerland, and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy.
Shares of Bristol Myers have plunged 21.8% in the past year compared with the industry’s decline of 7.8%.
Image Source: Zacks Investment Research
Breyanzi sales totaled $364 million in 2023. The label expansion of the therapy should boost the top line.
In January 2024, the FDA also accepted BMY’s two supplemental biologics license applications (sBLA) seeking label expansion for Breyanzi in two new indications. The sBLAs are seeking approval for Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a BTK inhibitor.
With the FDA granting a priority review to both sBLAs for Breyanzi, a decision from the regulatory body is expected on May 23, 2024, for the relapsed/refractory FL indication, and on May 31, 2024, for the relapsed/refractory MCL indication.
However, Breyanzi carries a boxed warning of cytokine release syndrome, neurologic toxicities and secondary hematological malignancies.
We remind investors that the FDA recently asked Gilead Sciences, Inc., Johnson & Johnson (JNJ - Free Report) and Novartis to add “boxed warning” to the labels of their T-cell immunotherapies, per Reuters.
The regulatory body sent letters to these companies stating that it had identified adverse events and clinical trial reports describing T-cell malignancies. The agency has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies, including BMY’s Abecma and Breyanzi.
Earlier, there were reports that the FDA’s staff was unclear if Johnson & Johnson and Bristol Myers Squibb's cell therapies would benefit blood cancer patients when given as early treatments. The therapies include JNJ’s Carvykti and BMY’s Abecma.
BMY is developing Abecma with its partner 2seventy bio, Inc.
Per a report, FDA's staff pointed to a pattern of early deaths in late-stage trials of the therapies, stating that it raised questions over the effectiveness of the treatments in extending the time patients live after receiving them.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #4 (Sell).
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 to 50 cents. Over the past year, ADMA shares have surged 92.3%.
In the past 30 days, the Zacks Consensus Estimate for GSK’s EPS has increased 4 cents to $4.03. During the same period, the estimate for GSK’s 2025 EPS has increased from $4.35 to $4.39.
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Bristol Myers (BMY) Gets FDA Nod for Breyanzi's Label Expansion
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has granted accelerated approval to chimeric antigen receptor (CAR) T cell therapy, Breyanzi (lisocabtagene maraleucel), for one more indication.
The approval was granted for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. The accelerated approval was based on the response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with median duration of CR not reached, along with an established safety profile.
CLL and SLL are among the most common types of B-cell lymphoma, and patients often experience relapse or become refractory following early-line treatment with targeted therapies, including BTK- and BCL-2 inhibitors.
Hence, the approval of Breyanzi in relapsed or refractory CLL and SLL after treatment with prior BTKi and BCL2i shifts the treatment paradigm from continuous therapy with sequential regimens to overcome drug resistance to a one-time personalized T-cell-based approach that has the potential to offer patients complete and lasting remission.
Bristol Myers Squibb Company Price and Consensus
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
Breyanzi is a CD19-directed genetically modified autologous T cell immunotherapy that is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment.
The therapy is approved in the United States, Japan and Europe for the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL), and in Japan, Europe, Switzerland, and Canada for relapsed and refractory LBCL after two or more lines of systemic therapy.
Shares of Bristol Myers have plunged 21.8% in the past year compared with the industry’s decline of 7.8%.
Image Source: Zacks Investment Research
Breyanzi sales totaled $364 million in 2023. The label expansion of the therapy should boost the top line.
In January 2024, the FDA also accepted BMY’s two supplemental biologics license applications (sBLA) seeking label expansion for Breyanzi in two new indications. The sBLAs are seeking approval for Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a BTK inhibitor.
With the FDA granting a priority review to both sBLAs for Breyanzi, a decision from the regulatory body is expected on May 23, 2024, for the relapsed/refractory FL indication, and on May 31, 2024, for the relapsed/refractory MCL indication.
However, Breyanzi carries a boxed warning of cytokine release syndrome, neurologic toxicities and secondary hematological malignancies.
We remind investors that the FDA recently asked Gilead Sciences, Inc., Johnson & Johnson (JNJ - Free Report) and Novartis to add “boxed warning” to the labels of their T-cell immunotherapies, per Reuters.
The regulatory body sent letters to these companies stating that it had identified adverse events and clinical trial reports describing T-cell malignancies. The agency has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies, including BMY’s Abecma and Breyanzi.
Earlier, there were reports that the FDA’s staff was unclear if Johnson & Johnson and Bristol Myers Squibb's cell therapies would benefit blood cancer patients when given as early treatments. The therapies include JNJ’s Carvykti and BMY’s Abecma.
BMY is developing Abecma with its partner 2seventy bio, Inc.
Per a report, FDA's staff pointed to a pattern of early deaths in late-stage trials of the therapies, stating that it raised questions over the effectiveness of the treatments in extending the time patients live after receiving them.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) and GSK plc (GSK - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), GSK carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 to 50 cents. Over the past year, ADMA shares have surged 92.3%.
In the past 30 days, the Zacks Consensus Estimate for GSK’s EPS has increased 4 cents to $4.03. During the same period, the estimate for GSK’s 2025 EPS has increased from $4.35 to $4.39.