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FDA begins speedy review of BMS’ CAR-T liso-cel

Agency sets target action date of 17 August for final decision

BMS

The US Food and Drug Administration has accepted an application for Bristol-Myers Squibb’s CAR-T therapy lisocabtagene maraleucel, kick-starting a priority review of the drug.

Liso-cel is a novel treatment for relapsed/refractory large B-cell lymphoma, and BMS is aiming for an approval of the CAR-T in the later line of the treatment pathway, for patients who have received at least two prior therapies.

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

The FDA biologics license application was based on results from the TRANSCEND NHL 001 study, in which liso-cel achieved a 53% complete response rate and an overall response rate of 73% in the patient population.

“Based on the TRANSCEND NHL 001 data, liso-cel has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed,” said Stanley Frankel, senior vice president, cellular therapy development, BMS.

BMS acquired liso-cel following its $6bn takeover of Celgene, and is one of the drugs critical to the potential payout of the merger in contingent value rights. Prior to the takeover, Celgene had forecast that liso-cel could become a $3bn product, dependent on regulatory approval.

If it does receive approval, liso-cel will come onto the market after rival Novartis’ Kymriah (tisangenlecleucel) and Gilead Sciences’ Yescarta (axicabtagene ciloleucel).

Last December, BMS successfully sued Gilead over the alleged patent infringement of Yescarta, winning $585m in damages plus a 27.6% running royalty on all sales of the CAR-T therapy.

The lawsuit argued that Gilead subsidiary Kite Therapeutics infringed on a patent licensed by BMS’ Juno Therapeutics from Sloan Kettering and Memorial Sloan Kettering Cancer Centre for exclusive rights to its CAR-T technology.

BMS alleged that Kite scientists copied research from the scientists at Sloan Kettering to advance their own CAR-T development, which lead to the advanced regulatory approval of Yescarta.

In addition to liso-cel, BMS has another CAR-T therapy in the pipeline – its bluebird bio-partnered BCMA-targeting therapy bb2121 for multiple myeloma.

However, on that front there are a number of rivals already developing anti-BCMA therapeutics, including Novartis/Poseida’s P-BCMA-01 – as well as other therapeutic approaches in development such as GlaxoSmithKline’s antibody-drug conjugate GSK2857916 and Amgen’s bispecific antibody AMG 420.

Following the acceptance of the priority review, the FDA has set a target action date for liso-cel due on the 17 August.

Article by
Lucy Parsons

14th February 2020

From: Regulatory

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