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Bristol Myers' (BMY) Abecma Gets ODAC Votes for Label Expansion
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Bristol Myers Squibb (BMY - Free Report) and partner 2seventy bio, Inc (TSVT - Free Report) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of Abecma’s (idecabtagene vicleucel) benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma (RRMM).
Abecma is a chimeric antigen receptor (CAR) T-cell therapy, already indicated for adult patients with triple-class exposed RRMM after four or more prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. BMY and TSVT are jointly developing and commercializing Abecma in the United States.
The companies are looking to expand Abecma’s label for myeloma patients earlier in their treatment course.
Eight out of the 12 members of the ODAC backed Abecma, stating that it demonstrated a favorable benefit/risk profile for triple-class exposed multiple myeloma in earlier lines of therapy.
The favorable voting was based on results from the late-stage KarMMa-3 study, including the key secondary endpoint of overall survival (OS).
The median OS was 41.4 months with Abecma and 37.9 months with standard regimens. However, the prespecified sensitivity analyses adjusting for crossover showed a median OS of 41.4 months for Abecma and 23.4 months for standard regimens, suggesting a positive trend in OS benefit for Abecma compared with the standard regimens.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
In November 2023, the FDA informed BMY and TSVT that the regulatory body would not be able to give a decision on the supplemental biologics license application (sBLA) for Abecma by the original target date of Dec 16, 2023, and that ODAC will meet to review data supporting the sBLA for Abecma.
The sBLA for Abecma in this indication remains under review with the FDA.
Although the regulatory body takes ODAC voting into account while deciding on approval, it is not bound by it. It has not yet assigned a new target action date for review of the sBLA.
The CAR T cell therapy was recently approved in Japan and Switzerland.
The Committee for Medicinal Products for Human Use of the European Medicines Agency also gave a positive opinion, recommending Abecma’s approval for patients with triple-class exposed, RRMM after at least two prior therapies based on KarMMa-3 study results.
Abecma sales totaled $472 million in 2023, up 22% year over year. A potential label expansion will further boost its sales.
Shares of Bristol Myers have plunged 22.1% in the past year compared with the industry’s decline of 8%.
Image Source: Zacks Investment Research
Last week, the FDA granted accelerated approval to BMY’s other CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. Breyanzi is already 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.
However, CAR T cell therapies have been under FDA scrutiny for the last few months. The FDA earlier 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 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.
Concurrently, the ODAC unanimously voted 11 to 0, supporting a favorable risk-benefit assessment of Carvykti for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent and who are refractory to lenalidomide. The favorable decision was based on results from the phase III CARTITUDE-4 study.
An sBLA for Carvykti, supported by the CARTITUDE-4 study, is currently under review by the FDA with a target action date of Apr 5, 2024.
Zacks Rank & a Stock 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 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’s shares have surged 94.5%.
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Bristol Myers' (BMY) Abecma Gets ODAC Votes for Label Expansion
Bristol Myers Squibb (BMY - Free Report) and partner 2seventy bio, Inc (TSVT - Free Report) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of Abecma’s (idecabtagene vicleucel) benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma (RRMM).
Abecma is a chimeric antigen receptor (CAR) T-cell therapy, already indicated for adult patients with triple-class exposed RRMM after four or more prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. BMY and TSVT are jointly developing and commercializing Abecma in the United States.
The companies are looking to expand Abecma’s label for myeloma patients earlier in their treatment course.
Eight out of the 12 members of the ODAC backed Abecma, stating that it demonstrated a favorable benefit/risk profile for triple-class exposed multiple myeloma in earlier lines of therapy.
The favorable voting was based on results from the late-stage KarMMa-3 study, including the key secondary endpoint of overall survival (OS).
The median OS was 41.4 months with Abecma and 37.9 months with standard regimens. However, the prespecified sensitivity analyses adjusting for crossover showed a median OS of 41.4 months for Abecma and 23.4 months for standard regimens, suggesting a positive trend in OS benefit for Abecma compared with the standard regimens.
Bristol Myers Squibb Company Price, Consensus and EPS Surprise
Bristol Myers Squibb Company price-consensus-eps-surprise-chart | Bristol Myers Squibb Company Quote
In November 2023, the FDA informed BMY and TSVT that the regulatory body would not be able to give a decision on the supplemental biologics license application (sBLA) for Abecma by the original target date of Dec 16, 2023, and that ODAC will meet to review data supporting the sBLA for Abecma.
The sBLA for Abecma in this indication remains under review with the FDA.
Although the regulatory body takes ODAC voting into account while deciding on approval, it is not bound by it. It has not yet assigned a new target action date for review of the sBLA.
The CAR T cell therapy was recently approved in Japan and Switzerland.
The Committee for Medicinal Products for Human Use of the European Medicines Agency also gave a positive opinion, recommending Abecma’s approval for patients with triple-class exposed, RRMM after at least two prior therapies based on KarMMa-3 study results.
Abecma sales totaled $472 million in 2023, up 22% year over year. A potential label expansion will further boost its sales.
Shares of Bristol Myers have plunged 22.1% in the past year compared with the industry’s decline of 8%.
Image Source: Zacks Investment Research
Last week, the FDA granted accelerated approval to BMY’s other CAR T cell therapy, Breyanzi (lisocabtagene maraleucel), for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Breyanzi is already 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.
However, CAR T cell therapies have been under FDA scrutiny for the last few months. The FDA earlier 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 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.
Concurrently, the ODAC unanimously voted 11 to 0, supporting a favorable risk-benefit assessment of Carvykti for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent and who are refractory to lenalidomide. The favorable decision was based on results from the phase III CARTITUDE-4 study.
An sBLA for Carvykti, supported by the CARTITUDE-4 study, is currently under review by the FDA with a target action date of Apr 5, 2024.
Zacks Rank & a Stock to Consider
Bristol Myers currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the healthcare sector is ADMA Biologics, Inc. (ADMA - Free Report) , which sports a Zacks Rank #1 (Strong 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 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’s shares have surged 94.5%.