Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma
30 May 2024
Drug ApprovalCell TherapyImmunotherapyAccelerated Approval
Preview
Source: FiercePharma
The recent Breyanzi approval follows two other recent regulatory wins for the Bristol Myers Squibb cell therapy.
In the years since gaining an initial FDA approval for Breyanzi, Bristol Myers Squibb has worked hard to expand the reach of its cell therapy. For the third time in as many months, those efforts have yielded a label expansion at the FDA.
Thursday, the company said Breyanzi secured FDA approval to treat certain patients with mantle cell lymphoma (MCL). The agency specifically endorsed the CAR-T therapy to treat adult patients with relapsed or refractory MCL who've received at least two other therapies, including one BTK inhibitor.
With the nod, Breyanzi becomes the first CAR-T cell therapy to gain FDA approval in four subtypes of non-Hodgkin lymphoma, BMS said in a press release.
The drug gained its original FDA nod in 2021 to treat certain patients with relapsed or refractory large B-cell lymphoma and expanded its reach in that disease the following year.
But in recent months, Bristol has accelerated its pace of regulatory expansion for the medicine.
In March, the drug scored an accelerated FDA nod in previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In doing so, the drug became the first cell therapy to enter the CLL/SLLCLL/SLL field, where BTK inhibitorsBTK inhibitors such as BeiGene's Brukinsa are typically used as first-line treatments.
And two weeks ago, Breyanzi gained an FDA approval to treat patients with relapsed or refractory follicular lymphoma (FL) after at least two prior lines of therapy. In that disease area, the drug followed rival cell therapies from Gilead Sciences and Novartis into the market.
The FDA's latest approval for Breyanzi is based on results from the MCL cohort of TRANSCEND NHL 001, which enrolled patients who had tried at least two lines of therapy, including a BTK inhibitor. The drug triggered a response in 85% of patients, with nearly 68% of recipients achieving a complete response, according to Bristol's release. More than half of responders remained in response one year after receiving the one-time therapy.
Breyanzi is given as a single infusion consisting of genetically reengineered T cells from individual patients.
Alongside these launch efforts, the med's sales have steadily ticked up over the years, hitting $87 million in 2021, $182 million in 2022 and $303 million in 2023.
Meanwhile, the drug's recent label expansions should "roughly double" the drug's addressable patient population, BMS chief commercial officer Adam Lenkowsky said on a recent conference call.
Besides Breyanzi, Bristol also markets another blood cancer cell therapy called Abecma. That drug generated $358 million last year.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.