Gilead and Kite nab another approval for Tecartus, as leading CAR-T portfolio continues to grow
Gilead and Kite took another step Friday toward expanding their franchise of CAR-T drugs, nabbing a new approval for Tecartus.
The FDA OK’ed the therapy for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, Gilead announced Friday. It’s the drug’s second indication after Gilead initially launched the CAR-T in 2020 for adults with relapsed or refractory mantle cell lymphoma.
A Kite spokesperson confirmed to Endpoints News that there will be no change in pricing for the new indication. When Tecartus was first approved, Gilead priced the drug at $373,000.
As Gilead continues building out the only commercial CAR-T portfolio with Tecartus and Yescarta, it will be seeking to ensure Tecartus has as smooth a rollout as possible in the new indication, Kite CEO Christi Shaw told Endpoints in an interview. The drug is already in use at over 100 treatment centers around the country for MCL, but uptake has been slow.
“Looking at the first launch in B cell lymphoma, only 2 out of 10 patients receive the drug, while 4 of 10 are referred,” Shaw said. “Now we’re seeing with future launches … there’s an increase in referrals to the treatment centers, so the share of the market is much higher, much quicker.”
Shaw added that she hopes similar pitfalls will be avoided as Tecartus and CAR-Ts become more common. In addition to the educational and outreach programs sponsored by Gilead, clinicians are becoming more adept at recognizing signs of adverse events, being able to treat them quicker than before.
CAR-Ts are inherently risky treatments, coming with a class-wide black box warning for cytokine release syndrome and neurological events. Friday’s new indication received one as well. In Gilead’s Tecartus trial for ALL, researchers saw two treatment-related deaths: one brain herniation and one case of septic shock. Shaw said she expects the new indication to come with the same warning.
The FDA, however, is clearly comfortable endorsing the benefits that outweigh those risks. Friday’s approval came from a study Gilead presented at #ASCO21 over the summer. Of 54 evaluable patients who received Tecartus in ALL, 65% saw their signs of cancer disappear. Additionally, 31% saw ongoing responses at the data cutoff, Kite said at the time, and 97% had deep molecular remission with undetectable minimal residual disease.
Bijal Shah, a trial investigator at the Moffitt Cancer Center in Tampa, FL, acknowledged the risks but said the relapsed and refractory patient populations don’t have much else to try.
“What is the alternative here?” Shah said. “What else are we going to do for them? It’s not like there’s this other tool that we’re going to pull out of our toolbox … we don’t have any other tools. We don’t have anything that we can successfully say, ‘A-ha! This is our answer.’ We’re still stuck.”
Gilead remains a step ahead of other big-name CAR-T players, though Bristol Myers Squibb is trying to close in. The Big Pharma netted approval for liso-cel earlier this year, with regulators OK’ing treatment for relapsed or refractory large B-cell lymphoma.