BMS files first drug from triple bet with Celgene shareholders with FDA

Bristol-Myers Squibb has filed the first of three key drugs with the FDA, part of a triple “bet” with former investors in Celgene that could pay out billions if they all successfully make it on to the market.

BMS said it has filed the CAR-T therapy lisocabtagene maraleucel (liso-cel) with the FDA for relapsed or refractory large B-cell lymphoma (LBCL) after at least two prior therapies.

Formerly known as JCAR017, the drug is a CAR-T (chimeric antigen receptor T-cell) therapy that is made from a patient’s own T-cells that are modified and reinjected to fight cancer.

The drug works as an anti-CD19 therapy and is made of individually formulated CD8+ and CD4+ CAR-T cells.

Filing is based on safety and efficacy from the TRANSCEND NHL 001, which tested liso-cel in 269 patients with with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL).

BMS presented data from the trial at the American Society of Hematology (ASH) conference earlier this month.

DLBCL is the most common and aggressive type of non-Hodgkin lymphoma, and accounts for three out of every five cases.

Approximately one-third of patients with DLBCL relapse after receiving first-line treatment, and about 10% have refractory disease.

Historically, median life expectancy for patients who relapse or are refractory to current standard of care treatments is approximately six months.

As a sweetener for Celgene’s shareholders during its $74 billion merger with BMS, the deal’s architects created a “contingent value right” (CVR) for each share of Celgene, with each CVR paying out $9 cash if three drugs get approved by the FDA in time for certain deadlines.

JCAR017 must get approved by 31st December 2020 along with multiple sclerosis drug ozanimod, while bb2121, the CAR-T developed in partnership with bluebird must get the nod by March 31, 2021.

The three drugs were considered the most significant assets in Celgene’s pipeline, and JCAR017 is potentially the first drug to spring from Celgene’s $9 billion acquisition of CAR-T specialist biotech Juno.

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