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Bristol Myers (BMY) Breyanzi Gets FDA Nod for Label Expansion
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Bristol Myers (BMY - Free Report) recently announced that the FDA has approved a label expansion of chimeric antigen receptor (CAR) T cell therapy, Breyanzi ((lisocabtagene maraleucel).
Breyanzi has been approved for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.
The therapy has been approved for patients who have a refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.
Breyanzi, a differentiated CAR T cell therapy, 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.
However, the label carries a boxed warning regarding cytokine release syndrome (CRS) and neurologic toxicities.
The approval was based on the phase III TRANSFORM study, wherein a single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with a median event-free survival of 10.1 months versus 2.3 months and a well-established safety profile. The approval was also based on data from the phase II PILOT study, the first and only company-sponsored study of a CAR T cell therapy in patients with primary refractory or relapsed LBCL who are not considered candidates for transplant, in which Breyanzi delivered deep and durable responses.
We remind investors that Breyanzi was approved by the FDA in February 2021 for the treatment of adult patients with relapsed or refractory (R/R) LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
With the latest two new indications, Breyanzi now has the broadest patient eligibility of any CAR T cell therapy in relapsed or refractory LBCL.
Earlier in the month, the European Medicines Agency validated the type II variation filing for the label expansion of Breyanzi.
Shares of Bristol Myers have rallied 27.9% so far this year against the industry’s decline of 21.7%.
Image Source: Zacks Investment Research
In 2021, Bristol Myers obtained 20 approvals for new drugs besides additional indications and formulations of currently marketed drugs in major markets, including regulatory approvals of Breyanzi and Abecma in hematology malignancies.
Approval of new drugs has added a new stream of revenues for Bristol Myers, which should propel growth in future quarters.
Competition is stiff in this space from the likes of Gilead’s (GILD - Free Report) Yescarta, among others.
Earlier in the year, Gilead’s Yescarta was approved by the FDA for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Gilead’s Yescarta is also the first CAR T-cell Therapy to receive NCCN treatment guideline category 1 recommendation.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.
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Bristol Myers (BMY) Breyanzi Gets FDA Nod for Label Expansion
Bristol Myers (BMY - Free Report) recently announced that the FDA has approved a label expansion of chimeric antigen receptor (CAR) T cell therapy, Breyanzi ((lisocabtagene maraleucel).
Breyanzi has been approved for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.
The therapy has been approved for patients who have a refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.
Breyanzi, a differentiated CAR T cell therapy, 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.
However, the label carries a boxed warning regarding cytokine release syndrome (CRS) and neurologic toxicities.
The approval was based on the phase III TRANSFORM study, wherein a single infusion of Breyanzi significantly outperformed the nearly 30-year standard of care with a median event-free survival of 10.1 months versus 2.3 months and a well-established safety profile. The approval was also based on data from the phase II PILOT study, the first and only company-sponsored study of a CAR T cell therapy in patients with primary refractory or relapsed LBCL who are not considered candidates for transplant, in which Breyanzi delivered deep and durable responses.
We remind investors that Breyanzi was approved by the FDA in February 2021 for the treatment of adult patients with relapsed or refractory (R/R) LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
With the latest two new indications, Breyanzi now has the broadest patient eligibility of any CAR T cell therapy in relapsed or refractory LBCL.
Earlier in the month, the European Medicines Agency validated the type II variation filing for the label expansion of Breyanzi.
Shares of Bristol Myers have rallied 27.9% so far this year against the industry’s decline of 21.7%.
Image Source: Zacks Investment Research
In 2021, Bristol Myers obtained 20 approvals for new drugs besides additional indications and formulations of currently marketed drugs in major markets, including regulatory approvals of Breyanzi and Abecma in hematology malignancies.
Approval of new drugs has added a new stream of revenues for Bristol Myers, which should propel growth in future quarters.
Competition is stiff in this space from the likes of Gilead’s (GILD - Free Report) Yescarta, among others.
Earlier in the year, Gilead’s Yescarta was approved by the FDA for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Gilead’s Yescarta is also the first CAR T-cell Therapy to receive NCCN treatment guideline category 1 recommendation.
Bristol Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks are Alkermes (ALKS - Free Report) and Geron Corporation (GERN - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.