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FDA delays BMS’ liso-cel decision, citing COVID-19 travel restrictions

Inspection of third-party manufacturing plant delayed due to COVID-19

The US Food and Drug Administration (FDA) has delayed a crucial decision for Bristol Myers Squibb’s CAR-T therapy liso-cel, a key asset gained in the company’s Celgene acquisition.

BMS picked up liso-cel 9 (lisocabtagene maraleucel) following its $74bn takeover of Celgene last year – the CAR-T therapy is one of the key assets critical to the potential payout of the merger in contingent value rights (CVR).

As part of the merger agreement, BMS agreed on a series of conditional payment to former Celgene shareholders or CVR holders, contingent on the regulatory approval of liso-cel by 31 December 2020, totalling an extra $6bn.

BMS also agreed similar conditional payments, dependent on approval, for Celgene’s multiple sclerosis therapy Zeposia (ozanimod) and another CAR-T therapy, ide-cel (idecabtagene vicleucel).

Zeposia was approved earlier this year, while ide-cel’s deadline is coming up in March 2021.

In February, the FDA kick-started a priority review of liso-cel for the treatment of relapsed/refractory large B-cell lymphoma for patients who have received at least two prior therapies.

The CAR-T therapy targets CD19, a protein which is highly expressed on the surface of B cells and remains following the transformation of these cells from normal to malignant.

The FDA biologics licence application (BLA) is based on results from the TRANSCEND NHL–1 study, in which liso-cel achieved a 53% complete response rate and an overall response rate of 73% in the patient population.

However, the FDA has now postponed its decision on liso-cel after it was unable to complete an inspection of a third-party manufacturing facility in the US, which is involved in making a component of the CAR-T therapy.

The agency blamed its inability to conduct the inspection on travel restrictions related to the COVID-19 pandemic and declined to provide a new anticipated action date for the liso-cel decision.

“Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel,” said Samit Hirawat, executive vice president, chief medical officer, global drug development, BMS.

“We are committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need,” he added.

BMS said in a statement that it is ‘committed’ to working with the FDA to ensure that the applications for both liso-cel and ide-cel achieve their respective regulator milestones, as required by the CVR agreement.

Article by
Lucy Parsons

20th November 2020

From: Regulatory



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