As Daiichi Sankyo puts its chips behind antibody-drug conjugates like the approved Enhertu and triple-negative breast cancer (TNBC) contender datopotamab deruxtecan (Dato-DXd), the Japanese pharma is returning the rights on another cutting-edge oncology med.
Wednesday, the company said it will transfer local marketing authorization of Kite Pharma’s CAR-T cell therapy Yescarta (axicabtagene ciloleucel) to Gilead Sciences’ Japanese bureau. The update revises a 2017 pact between Daiichi and Kite—later bought by Gilead that same year—which gave Daiichi exclusive rights to develop, manufacture and commercialize Yescarta in Japan.
Under the new deal, a Kite Cell Therapy business unit at Gilead Sciences K.K.—the Foster City, California, drugmaker’s Japanese subsidiary—will manage sales and promotion of Yescarta in Japan in 2023, following the transfer of the drug’s marketing authorization.
Yescarta was approved in Japan to treat patients with relapsed or refractory large B-cell lymphomas in January 2021, Gilead and Daiichi said in a release, noting Japan has the second-largest population of people diagnosed with non-Hodgkin lymphoma worldwide.
Kite is in charge of development, manufacturing and sales of the CAR-T in the United States, where Yescarta boasts a similar approval.
Stateside, Kite’s manufacturing plant in El Segundo, California, has been approved by Japanese regulators to make Yescarta for Japanese patients, with supply expected to kick off there in “early 2023,” the companies added in their release.
Gilead pointed out that the first Yescarta treatment center in Japan was authorized in December 2021, with six hospitals now cleared to administer the personalized therapy.
“We are confident that these changes will benefit patients in Japan by increasing capacity and support broader patient access to this important treatment for blood cancer patients and we remain committed to working together with Kite to ensure a smooth transfer during this transitional period,” Shoji Hirashima, head of Daiichi Sankyo’s Japan business unit, said in a statement.
Kite CEO Christi Shaw, for her part, said the company is excited to build on “momentum to accelerate efforts in Japan to maximize access and impact for patients” there.
It’s unclear exactly what sort of capacity and access issues the companies have run into in Japan. Daiichi Sankyo did not immediately respond to Fierce Pharma’s request for comment.
Many CAR-Ts have struggled to reach an ideal number of blood cancer patients thanks to the personalized medicines’ tricky manufacturing. Early last year, for instance, Bristol Myers Squibb revealed demand for its then-new multiple myeloma drug Abecma had outstripped capacity.
Last December, meanwhile, RBC Capital Markets analysts pinned $1.5 billion expectations on Gilead and Kite’s med, singling out the pace at which it reaches patients versus another BMS CAR-T for lymphoma dubbed Breyanzi.
On their respective websites at the time, Gilead said real-world data showed a median time of 16 days from blood draw to final product release for Yescarta, versus BMS’ 24-day target turnaround time.
CAR-Ts like Yescarta, Breyanzi and Abecma are personalized treatments that engineer each patient’s own T cells to fight cancer.