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Bristol Myers Scores Fifth FDA Approval for Cancer Therapy Breyanzi

MarketDash Editorial Team
3 days ago
Bristol Myers Squibb's CAR T cell therapy Breyanzi just earned its fifth FDA approval, this time for a rare blood cancer. The one-time infusion showed a 95.5% response rate in clinical trials, cementing Breyanzi's position as the most broadly approved CD19-directed CAR T therapy on the market.

Bristol Myers Squibb (BMY) just added another notch to its cancer-fighting belt. On Thursday, the FDA approved Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory marginal zone lymphoma, a rare type of blood cancer that's proven resistant to previous treatments.

This marks the fifth FDA approval for Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy. That's more approvals than any other CD19-directed CAR T therapy on the market, which is exactly the kind of distinction Bristol Myers wants when competing in the increasingly crowded cell therapy space.

Here's what makes CAR T therapy interesting: it's essentially reprogramming a patient's own immune cells to hunt down cancer. Breyanzi is given as a one-time infusion, which beats the alternative of ongoing treatment regimens that can stretch for months or years.

The Clinical Data That Sealed the Deal

The FDA based its approval on results from the marginal zone lymphoma cohort in the TRANSCEND FL study. The numbers are genuinely impressive. Among patients in the third-line plus setting included in the primary efficacy analysis, the overall response rate hit 95.5%. That means nearly every patient showed either a partial or complete response to treatment.

Even better, the complete response rate reached 62.1%, meaning more than six out of ten patients saw their cancer effectively disappear. The median duration of response wasn't even reached during the study period, and 90.1% of responders were still in response at the 24-month mark. In cancer therapy terms, those are the kind of results that get regulators excited.

Insurance Coverage and Patient Support

CAR T therapies don't come cheap, but Bristol Myers says Breyanzi is broadly covered by commercial and government insurance programs across the United States. The company also offers various programs and resources designed to help patients and their care partners navigate the treatment journey, which matters when you're dealing with cutting-edge cell therapy that requires careful coordination.

Building a Global Footprint

This isn't just a U.S. story. Back in March, the European Commission approved Breyanzi for adult patients with relapsed or refractory follicular lymphoma who've been through two or more lines of systemic therapy. Bristol Myers is clearly working to establish Breyanzi as a go-to option for blood cancers on both sides of the Atlantic.

The competitive landscape keeps evolving, though. In November, the FDA approved Genmab A/S (GMAB) Epkinly (epcoritamab-bysp) combined with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. Different mechanisms, same patient population Bristol Myers is targeting.

Bristol Myers Squibb shares were up 0.09% at $51.99 during premarket trading on Friday.

Back to News

Bristol Myers Scores Fifth FDA Approval for Cancer Therapy Breyanzi

MarketDash Editorial Team
3 days ago
Bristol Myers Squibb's CAR T cell therapy Breyanzi just earned its fifth FDA approval, this time for a rare blood cancer. The one-time infusion showed a 95.5% response rate in clinical trials, cementing Breyanzi's position as the most broadly approved CD19-directed CAR T therapy on the market.

Bristol Myers Squibb (BMY) just added another notch to its cancer-fighting belt. On Thursday, the FDA approved Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory marginal zone lymphoma, a rare type of blood cancer that's proven resistant to previous treatments.

This marks the fifth FDA approval for Breyanzi, a CD19-directed chimeric antigen receptor (CAR) T cell therapy. That's more approvals than any other CD19-directed CAR T therapy on the market, which is exactly the kind of distinction Bristol Myers wants when competing in the increasingly crowded cell therapy space.

Here's what makes CAR T therapy interesting: it's essentially reprogramming a patient's own immune cells to hunt down cancer. Breyanzi is given as a one-time infusion, which beats the alternative of ongoing treatment regimens that can stretch for months or years.

The Clinical Data That Sealed the Deal

The FDA based its approval on results from the marginal zone lymphoma cohort in the TRANSCEND FL study. The numbers are genuinely impressive. Among patients in the third-line plus setting included in the primary efficacy analysis, the overall response rate hit 95.5%. That means nearly every patient showed either a partial or complete response to treatment.

Even better, the complete response rate reached 62.1%, meaning more than six out of ten patients saw their cancer effectively disappear. The median duration of response wasn't even reached during the study period, and 90.1% of responders were still in response at the 24-month mark. In cancer therapy terms, those are the kind of results that get regulators excited.

Insurance Coverage and Patient Support

CAR T therapies don't come cheap, but Bristol Myers says Breyanzi is broadly covered by commercial and government insurance programs across the United States. The company also offers various programs and resources designed to help patients and their care partners navigate the treatment journey, which matters when you're dealing with cutting-edge cell therapy that requires careful coordination.

Building a Global Footprint

This isn't just a U.S. story. Back in March, the European Commission approved Breyanzi for adult patients with relapsed or refractory follicular lymphoma who've been through two or more lines of systemic therapy. Bristol Myers is clearly working to establish Breyanzi as a go-to option for blood cancers on both sides of the Atlantic.

The competitive landscape keeps evolving, though. In November, the FDA approved Genmab A/S (GMAB) Epkinly (epcoritamab-bysp) combined with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. Different mechanisms, same patient population Bristol Myers is targeting.

Bristol Myers Squibb shares were up 0.09% at $51.99 during premarket trading on Friday.