Recent Updates on CAR T-Cell Therapy: FDA Approvals and Patent Litigation

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On Feb. 5, 2021, the Food and Drug Administration (FDA) granted approval for a new CAR T-cell therapy, Breyanzi® (lisocabtagene maraleucel), to Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). Breyanzi® is indicated for the treatment of relapsed/refractory large B-cell lymphoma in adults who have not responded to at least two other systemic treatments. It is the third CAR T-cell therapy approved by the FDA for certain types of non-Hodgkin’s lymphoma (NHL), which include diffuse large B-cell lymphoma (DLBCL), the most common type of NHL in adults. Earlier CAR T-cell therapy approvals include Novartis’ Kymriah® (tisagenlecleucel), which was approved on Aug. 30, 2017, and May 1, 2018, for the treatment of relapsed/refractory acute lymphocytic leukemia (ALL) and relapsed/refractory large B-cell lymphoma, respectively. Also, Kite Pharma/Gilead’s Yescarta® (axicabtagene ciloleucel) was approved on Oct. 18, 2017, for the treatment of certain types of relapsed/refractory large B-cell lymphoma. All three CAR T-cell therapies target the CD19 antigen.

FDA approval of Breyanzi® was based on safety and efficacy data from TRANSCEND NHL 001, a multicenter clinical trial in which 268 patients with relapsed/refractory large B-cell lymphoma received Breyanzi®. In 192 patients who were treated with Breyanzi® at a dose of 50 to 110 x 106 CAR-positive viable T-cells, the overall response rate was 73%, with 54% of patients achieving a complete response. In patients who responded, the median duration of response was 16.7 months.

BMS acquired Breyanzi® in 2019 as part of its buyout of Celgene for $74 billion. In its acquisition of Celgene, BMS also obtained orva-cel, a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy developed by Juno Therapeutics (and acquired by Celgene). Notably, in December 2020 BMS disclosed a loss of $470 million in research and development expenses following the decision to discontinue development of the orva-cel program, choosing to focus on ide-cel instead. Ide-cel, like orva-cel, is a BCMA-directed CAR T-cell therapy. It was developed by Celgene and partner Bluebird Bio and treats relapsed and refractory multiple myeloma. In September 2019, the FDA accepted the Biologics License Application for ide-cel. The FDA is scheduled to render a decision on ide-cel by March 31, 2021.  

As an update to our previous post regarding a patent litigation involving Kite’s Yescarta®, a California district court judge awarded Juno Therapeutics and Sloan Kettering nearly $389.2 million in enhanced damages, bringing the total amount of damages to more than $1.2 billion, after a jury found that Kite Pharma willfully infringed Sloan Kettering’s CAR T-cell patent. Kite Pharma appealed to the Federal Circuit, arguing that the patent was invalid for lack of written description and enablement. Briefing was completed on Feb. 8, 2021. Oral arguments have not been scheduled.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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