CAR-T, EMA, Regulatory

Eyeing a fast pitch for quick OK in race with bluebird, J&J/Legend team enjoys a regulatory embrace for their rival BCMA CAR-T

J&J and its partners at Legend just picked up bragging rights to the EMA’s VIP program for their made-in-China BCMA CAR-T, offering some much-needed regulatory love after a few influential analysts turned a cold shoulder to it last year.

The decision to bestow their Prime designation on JNJ-68284528 is based on LEGEND-2 data for multiple myeloma we saw at ASH last year — which is what underwhelmed some of the analysts — as well as some data the industry has yet to see from a Phase I/II study dubbed CARTITUDE-1. And J&J plans to take maximum advantage of the open doors in Amsterdam as it hustles up a fast pitch for a quick approval.

Sjaak Bot

“We hope to bring this important advance to patients as quickly as possible and this PRIME designation, the first for Janssen, marks an important milestone towards potential market approval,” said Sjaak Bot, J&J’s regulatory chief in Europe.

That high regulatory opinion for new, unseen data might bolster expectations for the drug, which wowed ASCO back in the summer of 2017 while earning a dismissal from Nick Leschly. The CEO of bluebird has his own leading BCMA CAR-T — bb2121, partnered with Celgene and now headed into Bristol-Myers Squibb’s pipeline as a top late-stage prospect — which he’s asserted has been tested in sicker patients than Legend recruited.

Leschly gained some support for his position at ASH, when J&J/Legend revealed that their patients had had an average of 3 previous lines of treatment. That compares poorly with bluebird’s 7 previous lines of treatment, though Legend insisted that they were just being conservative in tracking earlier attempts to beat cancer.

No matter, said some bluebird supporters. Legend’s stellar data were based on a less sick patient population — advantage bluebird. This is a tough crowd, though, as Leschly found out when his own latest round of BCMA CAR-T data was seen as positive but a little light on the desired endurance.

Advantage J&J/Legend. And don’t think any of it was lost on Bristol-Myers or Celgene, which has a major CVR bonus tied to the near-term approval of bb2121 and two other top pivotal-stage drugs at Celgene.

This race has yet to be decided as a long lineup of players use new technologies to target BCMA in the hunt for a slice of a blockbuster market.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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