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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

The recent Breyanzi approval follows two other recent regulatory wins for the Bristol Myers Squibb cell therapy.

In the yearBreyanzigaining an initial FDA approval for Breyanzi, Bristol MyersBristol Myers Squibbard 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 seFDAed FDA approvaBreyanziatBristol Myers Squibbth mantle cell lymphoma (MCL). The agency specifically endorsed the CAR-T therapy to treat adult patients with relapsed or refractory MCL who've recFDAed at least two other therapies, including one BTK inhibitor.

With the nod, Breyanzi becoBreyanzifirst CARFDAcell therapy to gain FDA approval in fourmantle cell lymphoma (MCL)ymphoma, BMS said in a press release.CAR-T relapsed or refractory MCL BTK

The drug gaineBreyanziiginal FDA nod in 2CAR-T cellat certain patients with relapsed or refractory lanon-Hodgkin lymphomaand expanded its reach in that disease the following year.

But in recent months, BristolFDAs 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 field, where BTK inhibitors such as BeiGene's Brukinsa are typically used as first-line treatments.

And two weeks ago, Breyanzi gained an FDAFDAproval to treat patients wichronic lymphocytic leukemia (CLL)ar lsmall lymphocytic lymphoma (SLL)prior lines of therapy. In that disease area, the drug followed rivCLL/SLL CLL/SLL therapies froBTK inhibitors BTKilead Sciences and Novartis inBrukinsaarket.

The FDA's latest apBreyanzior BreyanziFDA based on results from the MCL corelapsed or refractory follicular lymphoma (FL)nts who had tried at least two lines of therapy, including a BTK inhibitor. The drug triggered a response in 8Gilead Sciences withNovartis68% 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.

BreyFDAi is given as a single Breyanzi consisting of genetically reeMCLneered T cells from iNHLvidual patients.BTK

Breyanziom 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 lateBristols release, Bristol said it "has made continuous investments to increase manufacturing capacity and is prepared to meet demand for Breyanzi."FDA

Alongside these launch effortBristolmed's sales have steadily ticked up over the years, hitting $87 million in 2021, $182 million in 2022 and $303 mBreyanzin 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 BMSlion last year.

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机构

Bristol Myers Co.