Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma

2024-05-30

上市批准细胞疗法免疫疗法加速审批

Bristol Myers secures another FDA go-ahead for Breyanzi, this time in mantle cell lymphoma

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来源: 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/SLL CLL/SLL field, where BTK inhibitors BTK 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.

Aside from Bristol's regulatory efforts to support the launch, the company has placed an emphasis on boosting its manufacturing capacity. Part of that effort includes the establishment of a Massachusetts production facility, which scored its own FDA go-ahead last year.

In its latest press release, Bristol said it "has made continuous investments to increase manufacturing capacity and is prepared to meet demand for Breyanzi."

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.